meloxicam: what the FDA reviewed for dog products
17 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing meloxicam, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Cats (feline) for this supplement; product also labeled for dogs; Dogs; Dogs and Cats; Dogs and cats.
Products
- Loxicom® (NADA/ANADA 200-491)
- Loxicom® (NADA/ANADA 200-497)
- Loxicom® (NADA/ANADA 200-786)
- Meloxicam (NADA/ANADA 200-727)
- Meloxicam Injection (NADA/ANADA 200-485)
- Meloxicam Oral Suspension (NADA/ANADA ANADA 200-817)
- Meloxicam Oral Suspension (NADA/ANADA ANADA 200-856)
- Meloxicam Solution for Injection (NADA/ANADA 200-540)
- Meloxidyl® (NADA/ANADA 200-550)
- Meloxisol™ (NADA/ANADA ANADA 200-789)
- Meloxisol™ (NADA/ANADA ANADA 200-794)
- Meloxisol™ (NADA/ANADA ANADA 200-816)
- Metacam® 5 mg/mL Solution for Injection (NADA/ANADA 141-219)
- Metacam® Oral Suspension (NADA/ANADA 141-213)
- OroCAM® Transmucosal Oral Spray (NADA/ANADA 141-346)
Metacam® Oral Suspension NADA 141-213, Original approval, April 15, 2003; sponsor Boehringer lngelheim Animal Health USA, Inc.; species: Dogs; foi_id 736; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.2 mg/kg on the first day, then 0.1 mg/kg, oral (mixed with food or directly into the mouth), once daily, Initial dose only on the first day of treatment; field studies dosed for 14 days.
Metacam® Oral Suspension should be administered initially at 0.2 mg/kg body weight only on the first day of treatment. For all treatm ents after the first day, Metacam® Oral Suspension should be administered once daily at 0.1 mg/kg body weight.
Target-animal safety
dose multiples 1X, 3X, 5X; duration 26 weeks (initial dose Day 1, maintenance dose Days 2-182); animals 3 males and 3 females in each of four groups.
Twenty-four purebred beagle dogs were divided into four groups, each with 3 males and 3 females. At commencement of treatment, the animals were between 8 and 10 months of age and weighed between 6.8 and 12.0 kg.
| Finding | Quote |
|---|---|
| Decreased red blood cell counts in 3X and 5X dogs; RBC significantly lower in 5X vs control. | Decreased red blood cell counts were seen in four 3X and three 5X dogs. |
| Regenerative anemia in two 3X and one 5X dogs. | There was evidence of regenerative anemia (decreased red blood cell count, hematocrit and hemoglobin with increased mean corpuscular volume) in two 3X and one 5X dogs. |
| Albumin significantly lower in 3X (day 176) and 5X (days 22, 51, 176). | Albumin was noted to be statistically significantly lower (p=0.015) on day 176 in the 3X dose group, and on days 22, 51 and 176 in the 5X dose group. |
| Macroscopic gastric/duodenal changes in four meloxicam-treated dogs. | Macroscopic changes were observed in four dogs administered meloxicam. One dog in the 1X group had multifocal pinpoint red foci in the stomach. |
| Conclusion: 0.1 mg/kg/day safe for 26 weeks; NSAID-type effects at 0.3 and 0.5 mg/kg/day. | The oral administration of meloxicam to dogs for 26 weeks at the 0.1 mg/kg/day dose was found to be safe. Typical non-steroidal anti-inflammatory drug-related effects were seen at the 0.3 and 0.5 mg/kg/day doses. |
Effectiveness
Field Study #1 (635-0180-98-006): multi-site (21 clinics, US and Canada), placebo-controlled field study; initial 0.2 mg/kg subcutaneous dose on day 1 followed by 0.1 mg/kg Metacam Oral Suspension once daily for 14 days total; examinations day 1, 8 and 15.; n = 224 (109 meloxicam, 115 placebo); primary endpoint: Investigator scores (1-5) for lameness, weight bearing and pain on palpation of the affected limb; investigator and owner overall evaluations.; result: Statistically significant improvement vs placebo in lameness score at days 8 and 15 (p=0.0080, p=0.0153), palpation pain at days 8 and 15 (p=0.0048, p=0.0271) and weight bearing at day 15 (p=0.0257); investigator (60.2% vs 37.3%, day 15) and owner (61.2% vs 32.4%, day 15) overall improvement significant.
Two hundred twenty-four client owned dogs participated in the study. Of the 224 cases, 109 received meloxicam and 115 received a placebo.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 32/109 | 15/115 | Adverse reaction Meloxicam no. of dogs (total=109) Placebo no. of dogs (total=115) Vomiting 32 15 Diarrhea/Soft Stool 15 11 Inappetance 3 0 Bloody Stool 1 0 |
| Diarrhea/Soft Stool | 15/109 | 11/115 | Adverse reaction Meloxicam no. of dogs (total=109) Placebo no. of dogs (total=115) Vomiting 32 15 Diarrhea/Soft Stool 15 11 Inappetance 3 0 Bloody Stool 1 0 |
| Inappetance | 3/109 | 0/115 | Adverse reaction Meloxicam no. of dogs (total=109) Placebo no. of dogs (total=115) Vomiting 32 15 Diarrhea/Soft Stool 15 11 Inappetance 3 0 Bloody Stool 1 0 |
| Bloody Stool | 1/109 | 0/115 | Adverse reaction Meloxicam no. of dogs (total=109) Placebo no. of dogs (total=115) Vomiting 32 15 Diarrhea/Soft Stool 15 11 Inappetance 3 0 Bloody Stool 1 0 |
Extraction notes: No pharmacokinetic parameters are reported in this summary. Effectiveness taken from Field Study #1, in which the day-1 loading dose was given subcutaneously (injectable) with oral suspension thereafter; Field Study #2 (oral-only, n=82: 48 meloxicam/34 placebo) showed numerical but mostly non-significant improvement. Adverse reactions are from the Field Study #1 table (counts of dogs). Target animal safety uses the 26-week study (6150-0987-00C-06); a 42-day study at the same 1X/3X/5X multiples (n=24) and an acute IV escalation study (n=4, 2-12 mg/kg) are also summarized. The dose_regimen quote copies the source's 'treatm ents' spacing artifact.
Loxicom® NADA 200-786, Original approval, April 20, 2026; sponsor Norbrook Laboratories, Ltd.; species: Dogs; foi_id 18346; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.09 mg/lb (0.2 mg/kg) on the first day, then 0.045 mg/lb (0.1 mg/kg), Oral, once daily, loading dose on day 1 only; maintenance dose for all treatments after day 1; syringes calibrated to deliver the daily maintenance dose in pounds
Loxicom® oral suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, Loxicom® oral suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/kg).
Extraction notes: Generic (ANADA) 0.5 mg/mL strength of Loxicom; RLNAD Metacam 0.5 mg/mL (NADA 141-213). Updated FOI summary (appendix dated June 25, 2026 adds a Bioequivalence Waiver section). No in vivo study in this summary: bioequivalence relies on the pivotal blood-level study of the 1.5 mg/mL Loxicom suspension (ANADA 200-497) plus comparative in vitro dissolution (USP Type 2 paddles, pH 7.5 phosphate buffer, 25 rpm) showing >85% dissolved in 15 minutes for generic 0.5 mg/mL, generic 1.5 mg/mL and RLNAD 1.5 mg/mL, so a biowaiver was granted. No effectiveness, target animal safety or PK data.
Meloxidyl® NADA 200-550, Original approval, August 02, 2013; sponsor Ceva Sante Animale; species: Dogs; foi_id 1234; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.09 mg/lb (0.2 mg/kg) on the first day, then 0.045 mg/lb (0.1 mg/kg), Oral, once daily, loading dose on day 1 only; maintenance dose for all treatments after day 1; syringes calibrated to deliver the daily maintenance dose in lbs
MELOXIDYL Oral Suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, MELOXIDYL Oral Suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/kg).
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | MELOXIDYL 33939 vs METACAM 35102 (mg/L)*hr geometric means; CI 91.18% to 102.54% | bioequivalence study; single oral dose of 1.5 mg/mL suspension, 24 fasted healthy female Beagles, 2-period crossover, 14-day washout; row columns: MELOXIDYL mean, METACAM mean, lower bound, upper bound of 90% CI; unit printed as (mg/L)*hr. in the summary | AUC (mg/L)*hr. 33939* 35102* 91.18% 102.54% |
| cmax | MELOXIDYL 1129 vs METACAM 1166 (unit printed as mg/mL) geometric means; CI 91.67% to 102.17% | same study; row columns: MELOXIDYL mean, METACAM mean, lower bound, upper bound of 90% CI | CMAX (mg/mL) 1129* 1166* 91.67% 102.17% |
| tmax | MELOXIDYL 5.3 hours vs METACAM 4.4 hours (arithmetic means) | same study; no confidence interval | TMAX (hours) 5.3 ˆ 4.4 ˆ n/a n/a |
Effectiveness
NOT an effectiveness study: randomized, two-way crossover, single-dose, replicate-design blood-level bioequivalence study (2-period, 2-treatment, 14-day washout) of MELOXIDYL vs METACAM 1.5 mg/mL oral suspension in fasted healthy female Beagles (Sinclair Research Center, Study S10051).; n = 24; primary endpoint: AUC (0 to first value below LOQ) and CMAX; 90% CI on log scale within 80.00% to 125.00%; result: Both AUC and CMAX within bounds; products bioequivalent.
The study was conducted as a 2-period, 2-treatment crossover design using 24 dogs with a 14 day washout between periods.
Extraction notes: Generic (ANADA) of METACAM Oral Suspension (NADA 141-213). No effectiveness or target animal safety studies ('CVM did not require effectiveness studies for this approval'). The effectiveness field holds the bioequivalence study, labelled as such. PK rows quote flattened Table 1 rows; units are as printed in the summary ((mg/L)*hr. for AUC, mg/mL for CMAX) and appear inconsistent with the reported magnitudes. Dose used in the bioequivalence study is not stated numerically in the summary.
Meloxisol™ NADA ANADA 200-789, Original approval, August 11, 2026; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs and cats; foi_id 18769; FDA PDF
Indication
Dogs: control of pain and inflammation associated with osteoarthritis. Cats: control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery.
Dose regimen
0.09 mg/lb (0.2 mg/kg) initial single dose (dogs); followed after 24 hours by oral suspension at 0.045 mg/lb (0.1 mg/kg) daily, Intravenous (IV) or subcutaneous (SQ) injection (dogs); subcutaneous injection (cats), Single injected dose, then once-daily oral suspension from 24 hours later (dogs), Cats: single, one-time subcutaneous dose of 0.14 mg/lb (0.3 mg/kg); use of additional meloxicam or other NSAIDs is contraindicated
Dogs: Meloxisol™ Injection should be administered initially as a single dose at 0.09 mg/lb (0.2 mg/kg) body weight intravenously (IV) or subcutaneously (SQ), followed, after 24 hours, by Meloxisol™ oral suspension at the daily dose of 0.045 mg/lb (0.1 mg/kg) body weight, either mixed with food or placed directly in the mouth.
Effectiveness
Generic ANADA; no in vivo study. Biowaiver granted based on formulation characteristics (injectable solution, same active ingredient, concentration and dosage form as RLNAD Metacam NADA 141-219).; result: Biowaiver granted; effectiveness, target animal safety and human food safety data not required for the ANADA.
Based on the formulation characteristics of the generic product, Cronus Pharma Specialities India Private Ltd. was granted a biowaiver for the generic product Meloxisol™ (meloxicam) 5 mg/mL solution for injection.
Extraction notes: Generic (ANADA) injectable with biowaiver: summary contains no PK, target animal safety, effectiveness or adverse reaction data. 'effectiveness' records the biowaiver statement, not a study. Cat dose (0.14 mg/lb / 0.3 mg/kg SQ once) appears on the same General Information page.
Meloxisol™ NADA ANADA 200-794, Original approval, August 14, 2025; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 17325; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.09 mg/lb (0.2 mg/kg) on day 1, Oral, Once daily; maintenance dose after day 1 is 0.045 mg/lb (0.1 mg/kg) once daily, Initial dose only on the first day of treatment; syringes calibrated to deliver the daily maintenance dose in pounds
Meloxisol™ oral suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1,
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 25661.7 (ng/mL)*hour (geometric mean, generic) | Generic 1.5 mg/mL Meloxisol oral suspension (ANADA 200-816), 2.2 mg single oral dose, fasted intact male beagles, n=24 crossover (Study 19247). Table II.1 column order: parameter, generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI. | AUC (ng/mL)*hour 25661.7† 25701.4† 1.00 0.93 1.07 |
| auc | 25701.4 (ng/mL)*hour (geometric mean, RLNAD) | Same study; RLNAD (Metacam 1.5 mg/mL) column of Table II.1. | AUC (ng/mL)*hour 25661.7† 25701.4† 1.00 0.93 1.07 |
| other | AUC generic:RLNAD geometric mean ratio 1.00 (CI 0.93 to 1.07) | 90% confidence interval; acceptance limits 0.80 to 1.25. | AUC (ng/mL)*hour 25661.7† 25701.4† 1.00 0.93 1.07 |
| cmax | 827.5 ng/mL (geometric mean, generic) | Same study; generic column of Table II.1. | CMAX (ng/mL) 827.5† 863.4† 0.96 0.90 1.02 |
| cmax | 863.4 ng/mL (geometric mean, RLNAD) | Same study; RLNAD column of Table II.1. | CMAX (ng/mL) 827.5† 863.4† 0.96 0.90 1.02 |
| other | CMAX generic:RLNAD geometric mean ratio 0.96 (CI 0.90 to 1.02) | 90% confidence interval; acceptance limits 0.80 to 1.25. | CMAX (ng/mL) 827.5† 863.4† 0.96 0.90 1.02 |
| tmax | 4.13 hours (SD 1.80), generic | Arithmetic mean and SD; same study. | TMAX (hours) (SD)‡ 4.13 (1.80)‡ 3.40 (1.43)‡ NE NE NE |
| tmax | 3.40 hours (SD 1.43), RLNAD | Arithmetic mean and SD; same study. | TMAX (hours) (SD)‡ 4.13 (1.80)‡ 3.40 (1.43)‡ NE NE NE |
Effectiveness
Bioequivalence (not effectiveness) study: randomized, masked, two-period, two-sequence, single-dose crossover blood-level study of generic 1.5 mg/mL Meloxisol vs RLNAD 1.5 mg/mL Metacam in fasted dogs (Study No. 19247); the 0.5 mg/mL strength received a biowaiver based on comparative dissolution.; n = 24; primary endpoint: CMAX and AUC; 90% CI of geometric mean ratios within 0.80-1.25; result: Bioequivalence demonstrated between generic and RLNAD 1.5 mg/mL suspensions; biowaiver granted for 0.5 mg/mL strength.
The laboratory study was conducted as a randomized, masked, two-period, two- sequence, two-treatment, single-dose crossover design using 24 dogs with a 14-day washout between periods.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events (bioequivalence study) | There were no serious adverse events reported during the study. |
Extraction notes: Generic ANADA. PK values come from the bioequivalence Table II.1 (generic vs RLNAD), not from a stand-alone PK study. The label maintenance dose sentence ('Meloxisol™ oral suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/kg).') sits on the next page after a page break, so the dose_regimen quote covers only the initial dose. The in vivo study was conducted with the 1.5 mg/mL strength (ANADA 200-816); the 0.5 mg/mL product was granted a biowaiver.
Loxicom® NADA 200-491, Original approval, December 19, 2012; sponsor Norbrook Laboratories, Ltd.; species: Dogs and Cats; foi_id 1196; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs; control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery in cats.
Dose regimen
0.2 mg/kg single dose, then 0.1 mg/kg oral suspension daily (dogs), intravenous or subcutaneous injection, single injection, followed after 24 hours by once-daily oral suspension (dogs), Cats: single, one-time subcutaneous dose (printed in the summary as '0.3 mg/mL body weight'); additional meloxicam or other NSAIDs contraindicated
Dogs: LOXICOM 5 mg/mL Solution for Injection should be administered initially as a single dose at 0.2 mg/kg body weight intravenously or subcutaneously followed after 24 hours by meloxicam oral suspension at the daily dose of 0.1 mg/kg body weight, either mixed with food or placed directly into the mouth.
Extraction notes: Generic (ANADA) of METACAM (NADA 141-219). Waiver from an in vivo bioequivalence study granted on formulation characteristics. No effectiveness, target animal safety or PK studies in the summary. The cat dose is printed as '0.3 mg/mL body weight' (apparent typo for mg/kg) and is quoted as written in duration_or_conditions.
Meloxicam Injection NADA 200-485, Original approval, December 21, 2012; sponsor Accord Healthcare, Inc.; species: Dogs and cats; foi_id 1193; FDA PDF
Indication
Dogs: control of pain and inflammation associated with osteoarthritis. Cats: control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery.
Dose regimen
0.09 mg/lb (0.2 mg/kg) single dose, then 0.045 mg/lb (0.1 mg/kg) oral suspension daily (dogs), intravenous or subcutaneous injection (dogs); subcutaneous (cats), single injection, followed after 24 hours by once-daily oral suspension (dogs), Cats: single, one-time subcutaneous dose of 0.14 mg/lb (0.3 mg/kg); additional meloxicam or other NSAIDs contraindicated
Dogs: Administer initially as a single dose at 0.09 mg/lb (0.2 mg/kg) body weight intravenously (IV) or subcutaneously (SQ), followed, after 24 hours, by meloxicam oral suspension at the daily dose of 0.045 mg/lb (0.1 mg/kg) body weight, either mixed with food or placed directly in the mouth.
Extraction notes: Generic (ANADA) of METACAM Solution for Injection (NADA 141-219). Waiver from in vivo bioequivalence granted on formulation characteristics. No effectiveness, target animal safety or PK studies in the summary ('CVM did not require effectiveness studies for this approval'). Summary covers dogs and cats; dog dosage recorded in dose_regimen.
Meloxisol™ NADA ANADA 200-816, Original approval, July 11, 2025; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 17209; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.09 mg/lb (0.2 mg/kg) on day 1, Oral, Once daily; maintenance dose after day 1 is 0.045 mg/lb (0.1 mg/kg) once daily, Initial dose only on the first day of treatment; syringes calibrated to deliver the daily maintenance dose in pounds
Meloxisol™ oral suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1,
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 25661.7 (ng/mL)*hour (geometric mean, generic) | Generic 1.5 mg/mL Meloxisol oral suspension, 2.2 mg single oral dose, fasted intact male beagles (10 kg to 12 kg, 2 to 4 years), n=24 crossover (Study 19247). Table II.1 column order: parameter, generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI. | AUC (ng/mL)*hour 25661.7† 25701.4† 1.00 0.93 1.07 |
| auc | 25701.4 (ng/mL)*hour (geometric mean, RLNAD) | Same study; RLNAD (Metacam 1.5 mg/mL) column of Table II.1. | AUC (ng/mL)*hour 25661.7† 25701.4† 1.00 0.93 1.07 |
| other | AUC generic:RLNAD geometric mean ratio 1.00 (CI 0.93 to 1.07) | 90% confidence interval; acceptance limits 0.80 to 1.25. | AUC (ng/mL)*hour 25661.7† 25701.4† 1.00 0.93 1.07 |
| cmax | 827.5 ng/mL (geometric mean, generic) | Same study; generic column of Table II.1. | CMAX (ng/mL) 827.5† 863.4† 0.96 0.90 1.02 |
| cmax | 863.4 ng/mL (geometric mean, RLNAD) | Same study; RLNAD column of Table II.1. | CMAX (ng/mL) 827.5† 863.4† 0.96 0.90 1.02 |
| other | CMAX generic:RLNAD geometric mean ratio 0.96 (CI 0.90 to 1.02) | 90% confidence interval; acceptance limits 0.80 to 1.25. | CMAX (ng/mL) 827.5† 863.4† 0.96 0.90 1.02 |
| tmax | 4.13 hours (SD 1.80), generic | Arithmetic mean and SD; same study. | TMAX (hours) (SD)‡ 4.13 (1.80)‡ 3.40 (1.43)‡ NE NE NE |
| tmax | 3.40 hours (SD 1.43), RLNAD | Arithmetic mean and SD; same study. | TMAX (hours) (SD)‡ 4.13 (1.80)‡ 3.40 (1.43)‡ NE NE NE |
Effectiveness
Bioequivalence (not effectiveness) study: randomized, masked, two-period, two-sequence, single-dose crossover blood-level study of generic 1.5 mg/mL Meloxisol vs RLNAD 1.5 mg/mL Metacam in fasted dogs (Study No. 19247), conducted under GLP.; n = 24; primary endpoint: CMAX and AUC; 90% CI of geometric mean ratios within 0.80-1.25; result: Bioequivalence demonstrated between generic and RLNAD 1.5 mg/mL meloxicam oral suspensions.
The laboratory study was conducted as a randomized, masked, two-period, two-sequence, two-treatment, single-dose crossover design using 24 dogs with a 14-day washout between periods.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events (bioequivalence study) | There were no serious adverse events reported during the study. |
Extraction notes: Generic ANADA. PK values come from the bioequivalence Table II.1 (same Study No. 19247 also cited in ANADA 200-794). The label maintenance dose sentence ('Meloxisol™ oral suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/kg).') sits on the next page after a page break, so the dose_regimen quote covers only the initial dose.
Meloxicam Oral Suspension NADA ANADA 200-817, Original approval, July 21, 2025; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs; foi_id 17255; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.09 mg/lb (0.2 mg/kg) on day 1; then 0.045 mg/lb once daily, Oral, Once daily after day 1 (maintenance dose 0.045 mg/lb, i.e. 0.1 mg/kg), Initial dose only on the first day of treatment; syringes calibrated to deliver the daily maintenance dose in pounds
Meloxicam Oral Suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, Meloxicam Oral Suspension should be administered once daily at a dose of 0.045
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 34774.3 (ng/mL)*hour (geometric mean, generic) | Generic 1.5 mg/mL meloxicam oral suspension, 0.2 mg/kg single oral dose, fasted intact male dogs (10.4 kg to 12.8 kg, 1 to 4 years), n=24 crossover, 14-day washout (Study MELS-KC2-2218). Table II.1 column order: parameter, generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI. | AUC (ng/mL)*hour 34774.3† 34928.4† 1.0 0.96 1.04 |
| auc | 34928.4 (ng/mL)*hour (geometric mean, RLNAD) | Same study; RLNAD (Metacam 1.5 mg/mL) column of Table II.1. | AUC (ng/mL)*hour 34774.3† 34928.4† 1.0 0.96 1.04 |
| other | AUC generic:RLNAD geometric mean ratio 1.0 (CI 0.96 to 1.04) | 90% confidence interval; acceptance limits 0.80 to 1.25. | AUC (ng/mL)*hour 34774.3† 34928.4† 1.0 0.96 1.04 |
| cmax | 924.6 ng/mL (geometric mean, generic) | Same study; generic column of Table II.1. | CMAX (ng/mL) 924.6† 957.1† 0.97 0.94 0.99 |
| cmax | 957.1 ng/mL (geometric mean, RLNAD) | Same study; RLNAD column of Table II.1. | CMAX (ng/mL) 924.6† 957.1† 0.97 0.94 0.99 |
| other | CMAX generic:RLNAD geometric mean ratio 0.97 (CI 0.94 to 0.99) | 90% confidence interval; acceptance limits 0.80 to 1.25. | CMAX (ng/mL) 924.6† 957.1† 0.97 0.94 0.99 |
| tmax | 3.29 hours (SD 1.16), generic | Arithmetic mean and SD; same study. Table row flattened across lines by PDF extraction. | TMAX (hours) (SD)‡ 3.29 (1.16)‡ 3.21 (0.83)‡ NE NE NE |
| tmax | 3.21 hours (SD 0.83), RLNAD | Arithmetic mean and SD; same study. | TMAX (hours) (SD)‡ 3.29 (1.16)‡ 3.21 (0.83)‡ NE NE NE |
Effectiveness
Bioequivalence (not effectiveness) study: randomized, masked, two-period, two-sequence, single-dose crossover blood-level study of generic vs RLNAD 1.5 mg/mL meloxicam oral suspension at 0.2 mg/kg in fasted dogs (Study No. MELS-KC2-2218), GLP.; n = 24; primary endpoint: CMAX and AUC; 90% CI of geometric mean ratios within 0.80-1.25; result: Bioequivalence demonstrated between generic and RLNAD 1.5 mg/mL meloxicam oral suspensions.
The laboratory study was conducted as a randomized, masked two-period, two- sequence, two-treatment, single-dose crossover design using 24 dogs with a 14-day washout between periods.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events (bioequivalence study) | There were no serious adverse events reported during the study. |
Extraction notes: Generic ANADA. PK values come from the bioequivalence Table II.1. The dosage regimen sentence is split by a page break after '0.045', so the '(0.1 mg/kg)' maintenance unit is recorded in frequency rather than dose.
Meloxicam NADA 200-727, Original approval, July 29, 2022; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs and cats; foi_id 12709; FDA PDF
Indication
Dogs: control of pain and inflammation associated with osteoarthritis. Cats: control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery.
Dose regimen
0.09 mg/lb (0.2 mg/kg) single dose, then 0.045 mg/lb (0.1 mg/kg) oral suspension daily (dogs), intravenous or subcutaneous injection (dogs); subcutaneous (cats), single injection, followed after 24 hours by once-daily oral suspension (dogs), Cats: single, one-time subcutaneous dose of 0.14 mg/lb (0.3 mg/kg); additional meloxicam or other NSAIDs contraindicated; 1 mL graduated syringe recommended
Dogs: Meloxicam injection should be administered initially as a single dose, at 0.09 mg/lb (0.2 mg/kg) body weight intravenously (IV) or subcutaneously (SQ), followed, after 24 hours, by meloxicam oral suspension at the daily dose of 0.045 mg/lb (0.1 mg/kg) body weight, either mixed with food or placed directly in the mouth.
Extraction notes: Generic (ANADA) of Metacam 5 mg/mL solution for injection (NADA 141-219). Biowaiver granted on formulation characteristics. No effectiveness, target animal safety or PK studies in the summary (not required for an ANADA). Summary covers dogs and cats; dog dosage recorded in dose_regimen.
Meloxicam Oral Suspension NADA ANADA 200-856, Original approval, June 22, 2026; sponsor ZyVet Animal Health, Inc.; species: Dogs; foi_id 18572; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.09 mg/lb (0.2 mg/kg) on day 1; then 0.045 mg/lb (0.1 mg/kg) once daily, Oral, Once daily after day 1, Initial dose only on the first day of treatment; syringes calibrated to deliver the daily maintenance dose in pounds
Meloxicam Oral Suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, Meloxicam Oral Suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/ kg). The syringes are calibrated to deliver the daily maintenance dose in pounds.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 32160 (ng/mL)*hour (geometric mean, generic) | Generic 1.5 mg/mL meloxicam oral suspension, 0.2 mg/kg single oral dose, fasted intact male and female beagles (7.7 to 10.7 kg), n=26 crossover, 14-day washout (Study KFI-113-BC-3023). Table II.1 column order: parameter, generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI. | AUC (ng/mL)*hour 32160† 31211† 1.03 0.98 1.09 |
| auc | 31211 (ng/mL)*hour (geometric mean, RLNAD) | Same study; RLNAD (Metacam 1.5 mg/mL) column of Table II.1. | AUC (ng/mL)*hour 32160† 31211† 1.03 0.98 1.09 |
| other | AUC generic/RLNAD geometric mean ratio 1.03 (CI 0.98 to 1.09) | 90% confidence interval; acceptance limits 0.80 to 1.25. | AUC (ng/mL)*hour 32160† 31211† 1.03 0.98 1.09 |
| cmax | 876 ng/mL (geometric mean, generic) | Same study; generic column of Table II.1. | CMAX (ng/mL) 876† 902† 0.97 0.92 1.02 |
| cmax | 902 ng/mL (geometric mean, RLNAD) | Same study; RLNAD column of Table II.1. | CMAX (ng/mL) 876† 902† 0.97 0.92 1.02 |
| other | CMAX generic/RLNAD geometric mean ratio 0.97 (CI 0.92 to 1.02) | 90% confidence interval; acceptance limits 0.80 to 1.25. | CMAX (ng/mL) 876† 902† 0.97 0.92 1.02 |
| tmax | 2.83 hours (SD 1.10), generic | Arithmetic mean and SD; same study. | TMAX (hours) (SD‡) 2.83 (1.10)‡ 2.55 (1.22)‡ NE NE NE |
| tmax | 2.55 hours (SD 1.22), RLNAD | Arithmetic mean and SD; same study. | TMAX (hours) (SD‡) 2.83 (1.10)‡ 2.55 (1.22)‡ NE NE NE |
Effectiveness
Bioequivalence (not effectiveness) study: randomized, masked, two-period, two-sequence, two-treatment, single-dose crossover blood-level study of generic vs RLNAD 1.5 mg/mL meloxicam oral suspension at 0.2 mg/kg in fasted beagles (Study No. KFI-113-BC-3023), OECD GLP.; n = 26; primary endpoint: CMAX and AUC; 90% CI of geometric mean ratios within 0.80-1.25; result: Bioequivalence demonstrated between generic and RLNAD 1.5 mg/mL meloxicam oral suspensions.
The laboratory study was conducted as a randomized, masked, two-period, two- sequence, two-treatment, single-dose crossover design using 26 dogs with a 14-day washout between periods.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events related to test or reference article (bioequivalence study) | There were no serious adverse events related to the test or reference article reported during the study. |
Extraction notes: Generic ANADA. PK values come from the bioequivalence Table II.1. Label text reads '0.1 mg/ kg' with a stray space, quoted as extracted. Batch plan listed 0 parsed PK sentences because the General Information section was not parsed, but the bioequivalence table is present in the raw text.
Loxicom® NADA 200-497, Original approval, May 01, 2015; sponsor Norbrook Laboratories, Ltd.; species: Dogs; foi_id 1201; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.09 mg/lb (0.2 mg/kg) on the first day, then 0.045 mg/lb (0.1 mg/kg), Oral, once daily, loading dose on day 1; maintenance dose for all treatments after day 1
On the first day of treatment, administer 0.09 mg/lb (0.2 mg/kg). For all treatments after day 1, administer once daily at a dose of 0.045 mg/lb (0.1 mg/ kg).
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | test (LOXICOM) 22.7258 vs reference (METACAM) 23.5141 (mg/mL)*hour geometric means; CI 87.01% to 107.34% | bioequivalence study; single oral dose 0.2 mg/kg, 18 Beagles, two-period crossover, 35-day washout; row columns: test, reference, lower bound, upper bound of 90% CI; unit printed as (mg/mL)*hour in the summary | AUC (mg/mL)*hour 22.7258* 23.5141* 87.01% 107.34% |
| cmax | test 0.6023 vs reference 0.6383 mg/L geometric means; CI 87.24% to 102.07% | same study; row columns: test, reference, lower bound, upper bound of 90% CI | CMAX (mg/L) 0.6023* 0.6383* 87.24% 102.07% |
| tmax | test 5.7 hours vs reference 3.0 hours (arithmetic means) | same study; no confidence intervals estimated | TMAX (hour) 5.7† 3.0† NA NA |
| other | bioequivalence criteria met: AUC 87% to 107%, CMAX 87% to 102% | back-transformed 90% confidence intervals for the test/reference ratio | Bioequivalence criteria are met for LOXICOM for both AUC (87% to 107%) and CMAX (87% to 102%). |
Effectiveness
NOT an effectiveness study: in vivo blood-level bioequivalence study, two-period, two-treatment crossover with 35-day washout, LOXICOM vs METACAM 1.5 mg/mL oral suspension at 0.2 mg/kg in healthy Beagles (17 blood samples per dog per period to 120 hours).; n = Eighteen (six female, twelve male); primary endpoint: AUC (0 to last quantifiable) and CMAX; 90% CI of test/reference ratio within 80-125%; result: Bioequivalence criteria met (AUC 87% to 107%; CMAX 87% to 102%).
Study Animals: Eighteen healthy Beagle dogs; six female and twelve male dogs Age range: 1.5 to 8 years Weight: 11.0 to 16.1 kg. 3) Experimental Design: The study was conducted as a two-period, two-treatment, crossover design with a 35-day washout time between study periods.
Extraction notes: Generic (ANADA) of METACAM Oral Suspension (NADA 141-213). No effectiveness or target animal safety studies ('CVM did not require effectiveness studies for this approval'). The effectiveness field holds the bioequivalence study, labelled as such. PK rows quote flattened table rows (test, reference, lower bound, upper bound); AUC unit is printed as (mg/mL)*hour and CMAX as mg/L in the summary. n_dogs written as in the summary ('Eighteen').
OroCAM® Transmucosal Oral Spray NADA 141-346, Original approval, November 02, 2012; sponsor Zoetis Inc.; species: Dogs; foi_id 903; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.1 mg/kg, oral (transmucosal spray to buccal/gingival mucosa), once per day, Field study dosed for 28 days; metered pumps deliver 0.25, 0.5 or 1.075 mg per spray by body-weight band.
J. Dosage: 0.1 mg/kg, once per day K. Route of Administration: Oral
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| cmax | 0.6187 µg/mL (SD 0.0552) | meloxicam TMOS, single 2 mg dose (0.18-0.20 mg/kg), 30 min after feeding, 20 female beagles, crossover; reference Metacam Oral Suspension 0.6082 (0.0665) | Cmax, µg/mL 0.6187 (0.0552) 0.6082 (0.0665) |
| tmax | 4.5 hr (range 0.5-8) | meloxicam TMOS, single 2 mg dose (~0.2 mg/kg), fed, n=20; reference oral suspension 6.5 hr (range 2-12) | Tmax, hr 4.5 [0.5, 8]* 6.5 [2, 12]* |
| half-life | 30.053 hr (SD 3.672) | meloxicam TMOS, single ~0.2 mg/kg dose, fed, n=20; reference oral suspension 30.383 (3.060) | Half-life, hr 30.053 (3.672) 30.383 (3.060) |
| auc | AUClast 25.350 hr*µg/mL (SD 3.695) | meloxicam TMOS, single ~0.2 mg/kg dose, fed, n=20; reference oral suspension 25.980 (3.252) | AUClast, hr*µg/mL 25.350 (3.695) 25.980 (3.252) |
| auc | AUCinf 27.190 hr*µg/mL (SD 4.466) | meloxicam TMOS, single ~0.2 mg/kg dose, fed, n=20; reference oral suspension 27.900 (3.848) | AUCinf, hr*µg/mL 27.190 (4.466) 27.900 (3.848) |
| clearance | CL/F 0.0070 L/hr/kg (SD 0.0013) | meloxicam TMOS, single ~0.2 mg/kg dose, fed, n=20; reference oral suspension 0.0066 (0.0010) | CL/F, L/hr/kg 0.0070 (0.0013) 0.0066 (0.0010) |
| other | V/F 0.3000 L/kg (SD 0.0247) | meloxicam TMOS, single ~0.2 mg/kg dose, fed, n=20; reference oral suspension 0.2865 (0.0271) | V/F, L/kg 0.3000 (0.0247) 0.2865 (0.0271) |
| bioavailability | 98% (relative AUC vs Metacam Oral Suspension); Cmax 2% greater | comparative bioavailability crossover, n=20 fed beagles; no statistically significant differences for Cmax, AUCinf, AUClast | Mean Cmax is 2% greater following administration of the test transmucosal oral spray, but overall mean absorption (AUC) is 98% of the reference METACAM Oral Suspension. |
| half-life | 24.7 hr (range 21.7-30.4) | 0.1 mg/kg TMOS with esophageal occlusion under anesthesia, 3 female beagles (study MX05); 25.7 hr (23.4-29.0) without occlusion (MX06); dose normalized to 0.1 mg/kg | t½ (hr) 24.7 (21.7-30.4) 25.7 (23.4-29.0) |
| cmax | 0.39 µg/mL (Tmax 2 hr) | 0.1 mg/kg TMOS with esophageal occlusion, anesthetized, 3 female beagles (study MX05); 0.45 µg/mL in MX06 without occlusion | the Cmax associated with study MX05 was 0.39 µg/mL (Tmax = hr 2) |
| auc | AUC0-last 12.3 µg*hr/mL | 0.1 mg/kg TMOS with esophageal occlusion, 3 female beagles (study MX05, AUC to 72 hr); 11.2 in MX06 | The AUC0-last estimated in study MX05 was 12.3 µg*hr/mL. |
Target-animal safety
dose multiples 1x, 2x, 3x, 5x; duration 6 months (188 days); animals five groups of eight dogs each (4 males and 4 females).
Twenty male and twenty female Beagle dogs were selected and randomly allocated to five treatment groups of eight dogs each (4 males and 4 females).
| Finding | Quote |
|---|---|
| Vomiting, abnormal fecal consistency and blood in feces were the main clinical signs; most vomiting in 5x. | Vomiting, abnormal fecal consistency, and the presence of blood in the fecal material were the main adverse clinical signs observed during the study. |
| Lower mean albumin in 1x, 3x and 5x groups at week 4 (P<0.10). | Dogs in the 1x, 3x, and 5x treatment groups had statistically significantly different (P<0.10) mean albumin values on week 4, as compared to the control (0x) group, with lower values observed in the treated groups. |
| Potential test-article GI lesions in one 3x dog (fundic mucosa) and one 5x dog (duodenal erosions). | Potential test article-related changes were observed in the gastrointestinal tract of two dogs. |
| Quantifiable meloxicam found in all control dogs (contamination). | Quantifiable meloxicam concentrations were found in all control (0x) dogs, throughout the study. |
| Steady-state exposure increased less than proportionally with dose (3x gave 2.1 times 1x). | At the 3x dose level, plasma meloxicam concentrations were an average of 2.1 times greater than the concentrations at the 1x dose level. |
| Conclusion: all dogs survived; typical NSAID GI effects; adequate safety margin. | All dogs survived to the end of the 6 month study. Typical NSAID-induced gastrointestinal adverse effects were observed. An adequate safety margin was demonstrated in this study to support the use of meloxicam transmucosal oral spray for the control of pain and inflammation associated with osteoarthritis in dogs. |
Effectiveness
Placebo-controlled, randomized (2:1 meloxicam:vehicle), 14-site field study in client-owned dogs with osteoarthritis; 0.1 mg/kg TMOS once daily for 28 days; owner CSOM at Days 14 and 28, veterinary assessment Day 28.; n = 258 evaluated for effectiveness; 280 for safety; primary endpoint: Treatment success = reduction of at least 2 in total Client Specific Outcome Measure (CSOM) score at Day 28 vs enrollment (rescue or increase in any CSOM item = failure).; result: Treatment success 72.62% meloxicam (123/170) vs 46.85% placebo (42/88), p = 0.0030; secondary CSOM and owner global assessment favored meloxicam; veterinary pain and lameness scores not significant.
Effectiveness was evaluated in 258 dogs and field safety was evaluated in 280 dogs. Based on owner evaluated CSOM scores on Day 0 and 28, animals in the meloxicam treated group had a significantly different (p = 0.0030) and numerically higher treatment success compared to animals in the placebo group, with 72.62% versus 46.85% success rates, respectively
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 22/187 | 6/93 | Adverse Reaction* Meloxicam Transmucosal Oral Spray N = 187 Placebo (Vehicle) N = 93 Vomiting 22 6 Increased Liver Enzymes (ALT and/or Alk Phos) 11 6 Diarrhea 8 2 Lethargy 6 2 Inappetence 4 2 |
| Increased liver enzymes (ALT and/or Alk Phos) | 11/187 | 6/93 | Adverse Reaction* Meloxicam Transmucosal Oral Spray N = 187 Placebo (Vehicle) N = 93 Vomiting 22 6 Increased Liver Enzymes (ALT and/or Alk Phos) 11 6 Diarrhea 8 2 Lethargy 6 2 Inappetence 4 2 |
| Diarrhea | 8/187 | 2/93 | Adverse Reaction* Meloxicam Transmucosal Oral Spray N = 187 Placebo (Vehicle) N = 93 Vomiting 22 6 Increased Liver Enzymes (ALT and/or Alk Phos) 11 6 Diarrhea 8 2 Lethargy 6 2 Inappetence 4 2 |
| Lethargy | 6/187 | 2/93 | Adverse Reaction* Meloxicam Transmucosal Oral Spray N = 187 Placebo (Vehicle) N = 93 Vomiting 22 6 Increased Liver Enzymes (ALT and/or Alk Phos) 11 6 Diarrhea 8 2 Lethargy 6 2 Inappetence 4 2 |
| Inappetence | 4/187 | 2/93 | Adverse Reaction* Meloxicam Transmucosal Oral Spray N = 187 Placebo (Vehicle) N = 93 Vomiting 22 6 Increased Liver Enzymes (ALT and/or Alk Phos) 11 6 Diarrhea 8 2 Lethargy 6 2 Inappetence 4 2 |
Extraction notes: PK values are means (SD) from the comparative bioavailability crossover (Table 2) at ~0.2 mg/kg, plus the transmucosal-absorption study (Table 3, dose-normalized to 0.1 mg/kg; its AUC units are printed as mg*hr/mL and Cmax as mg/mL in the table but µg in the text). Adverse-reaction counts are dogs (may have more than one event) from Table 9; the group Ns (187/93) differ from the 258 effectiveness population. Six-month TAS study also reported 77 pump failures and endoscopic lesions in controls and treated dogs that were hard to interpret; a 3-month local tolerance study (n=16 at 1x) showed no dose-site effects.
Metacam® 5 mg/mL Solution for Injection NADA 141-219, Original approval, November 12, 2003; sponsor Boehringer lngelheim Animal Health USA, Inc.; species: Dogs; foi_id 750; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.2 mg/kg, intravenous or subcutaneous injection, one-time initial dose, Continue with Metacam Oral Suspension after 24 hours at 0.1 mg/kg once daily.
METACAM 5 mg/mL Solution for Injection should be administered initially as a one-time dose at 0.2 mg/kg body weight intravenously or subcutaneously. Continue with METACAM Oral Suspension after 24 hours at a daily dose of 0.1 mg/kg body weight, either mixed with food or placed directly into the mouth.
Target-animal safety
dose multiples 1x, 3x, 5x; duration 3 days (intravenous bolus once daily); animals 3 males and 3 females in each of four groups.
Twenty-four pure bred beag le dogs were divided into four groups each, with 3 males and 3 females. The study animals were between 11 and 13 months of age and weighed between 8.5 and 14.3 kg.
| Finding | Quote |
|---|---|
| Vomiting (one 1x, one 5x), fever in five dogs, occult fecal blood in three 5x dogs. | Vomiting occurred in one 1x and one 5x dog on Day 3. Fevers were observed in a total of five dogs, one each in the 1x and 3x groups, and three in the 5x treatment group. Occult fecal blood was observed on Day 3 in three 5x dogs. |
| Two 5x female dogs developed acute renal failure by day 4. | Both of these female dogs developed acute renal failure (ARF) by day 4 of the study. |
| Bilateral renal papillary necrosis in all three 5x females. | Microscopic renal changes, consisting of bilateral necrosis of the tip of the papilla, were seen in all three females of the 5x group. |
| Drug-related GI gross lesions: pyloric hemorrhage/erosions at 3x, jejunal/ileal congestion in four 5x dogs. | Dogs in the 3x group experienced pyloric mucosal hemorrhages and pyloric mucosal erosions. Areas of mucosal congestion were observed in the jejunum and ileum in four of the 5x dogs. These findings are considered drug-related. |
| Conclusion: safe at 1x; toxicity increased with dose. | This study demonstrated that meloxicam was safe when administered at the therapeutic (1x) level, but that toxicity increased at higher doses. |
Effectiveness
Field Study 635-0180-98-006: multi-site placebo-controlled field study (21 investigators, US/Canada); single subcutaneous 0.2 mg/kg dose of the injection on day 1 followed by 13 once-daily oral doses of 0.1 mg/kg oral suspension; examinations Day 1, 8 and 15.; n = 224 (109 meloxicam, 115 placebo); primary endpoint: Investigator scores (1-5) for lameness, weight bearing and pain on palpation of the affected limb; investigator and owner overall evaluations.; result: Significant improvement vs placebo in lameness score at Days 8 and 15 (p=0.0080, p=0.0153), pain on palpation at Days 8 and 15 (p=0.0048, p=0.0271) and weight bearing at Day 15 (p=0.0257); investigator and owner overall evaluations significant at Days 8 and 15 (p<0.05).
Two hundred twenty four client-owned dogs participated in the study. Of the 224 cases, 109 received meloxicam and 115 received a placebo.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 31/109 | 15/115 | Adverse reaction Meloxicam no. of dogs (total=109) Placebo no. of dogs (total=115) Vomiting 31 15 Diarrhea/Soft Stool 15 11 Inappetance 3 0 Bloody Stool 1 0 |
| Diarrhea/Soft Stool | 15/109 | 11/115 | Adverse reaction Meloxicam no. of dogs (total=109) Placebo no. of dogs (total=115) Vomiting 31 15 Diarrhea/Soft Stool 15 11 Inappetance 3 0 Bloody Stool 1 0 |
| Inappetance | 3/109 | 0/115 | Adverse reaction Meloxicam no. of dogs (total=109) Placebo no. of dogs (total=115) Vomiting 31 15 Diarrhea/Soft Stool 15 11 Inappetance 3 0 Bloody Stool 1 0 |
| Bloody Stool | 1/109 | 0/115 | Adverse reaction Meloxicam no. of dogs (total=109) Placebo no. of dogs (total=115) Vomiting 31 15 Diarrhea/Soft Stool 15 11 Inappetance 3 0 Bloody Stool 1 0 |
Extraction notes: No pharmacokinetic parameters are reported. The same field study (635-0180-98-006) supports both this NADA and NADA 141-213; this summary reports 31 vomiting dogs whereas the oral-suspension summary reports 32. Target animal safety uses the 3-day intravenous margin-of-safety study P98-BIVI008 (0/0.2/0.6/1.0 mg/kg/day, 1x/3x/5x); also summarized: acute IV escalation (n=4, 2-12 mg/kg, 10x-60x), single-dose SC local tolerance (pain on injection 1/8) and a buccal mucosal bleeding time study. The design quote preserves the source's 'beag le' spacing artifact.
Metacam® Oral Suspension NADA 141-213, Supplemental approval, October 28, 2004; sponsor Boehringer lngelheim Animal Health USA, Inc.; species: Dogs; foi_id 737; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
0.09 mg/lb (0.2 mg/kg) on the first day, then 0.045 mg/lb (0.1 mg/kg), oral (mixed with food or placed directly in the mouth), once daily, loading dose on day 1 only; maintenance dose thereafter; syringe calibrated to deliver the daily maintenance dose in pounds; 0.5 mg/mL and 1.5 mg/mL suspensions
METACAM Oral Suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, METACAM Oral Suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/kg).
Extraction notes: Supplemental approval (October 28, 2004) revising the dosage wording in 21 CFR 520.1350 and labeling (minor changes facilitating use; addition of a Post-Approval section). No new studies: effectiveness (dosage characterization, substantial evidence) and target animal safety sections refer to the original FOI summary dated April 15, 2003.
Metacam® 5 mg/mL Solution for Injection NADA 141-219, Supplemental approval, October 28, 2004; sponsor Boehringer lngelheim Animal Health USA, Inc.; species: Cats (feline) for this supplement; product also labeled for dogs; foi_id 751; FDA PDF
Indication
Dogs: control of pain and inflammation associated with osteoarthritis. Cats (claim added by this supplement): control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery.
Dose regimen
0.14 mg/lb (0.3 mg/kg), subcutaneous injection, single, one-time dose, cats, administered prior to surgery; additional meloxicam or other NSAIDs contraindicated
Administer a single, one-time subcutaneous dose k. Recommended Dosage: of METACAM 5 mg/mL Solution for Injection to cats at a dose of 0.14 mg/lb (0.3 mg/kg) body weight.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| protein binding | approximately 97% | feline plasma in vitro (ultrafiltration, radiolabelled meloxicam), 0.2-10 mcg/mL | Approximately 97% of the total drug concentrations of meloxicam measured in plasma represent drug that is bound to plasma proteins. |
| clearance | 0.21 mL/min/kg (IV, oral-vs-IV phase); 0.22 mL/min/kg (IV, SC-vs-IV phase) | cats, single IV 0.3 mg/kg, fasted, n=4 per phase (2 male, 2 female) | CL total mL/min/kg 0.21 (36) --- 0.22 (26) --- |
| other | volume of distribution (VD area) 0.28 L/kg (IV, oral-vs-IV phase); 0.27 L/kg (IV, SC-vs-IV phase) | cats, single IV 0.3 mg/kg | VD area L/kg 0.28 (7) --- 0.27 (5) --- |
| auc | AUCinf 26.1 mcg x hr/mL (IV, oral-vs-IV phase); 21.0 (oral); 24.0 (IV, SC-vs-IV phase); 24.9 (SC) | cats, single 0.3 mg/kg dose, crossover, fasted 12 h | AUCinf mcg x hr/mL 26.1 (35) 21.0 (44) 24.0 (28) 24.9 (5) |
| half-life | 14.5 hr (IV, oral-vs-IV phase); 15.6 hr (oral); 14.6 hr (IV, SC-vs-IV phase); 14.5 hr (SC) | cats, single 0.3 mg/kg dose | T½ hr 14.5 (31) 15.6 (37) 14.6 (31) 14.5 (36) |
| cmax | 0.9 (oral); 1.1 (SC) (table unit printed as mcg x hr/mL) | cats, single 0.3 mg/kg dose | Cmax mcg x hr/mL --- 0.9 (22) --- 1.1 (34) |
| tmax | 1.5 (oral); 1.5 (SC) (hours implied) | cats, single 0.3 mg/kg dose | Tmax --- 1.5 (67) --- 1.5 (28) |
| bioavailability | 0.83 (oral); 1.06 (SC) | cats, F = AUCinf oral or SC / AUCinf IV, 0.3 mg/kg | F --- 0.83 (49) --- 1.06 (29) |
Target-animal safety
dose multiples 0X (0 mg/kg/day), 1X (0.3 mg/kg/day), 3X (0.9 mg/kg/day), 5X (1.5 mg/kg/day); duration 3 days, subcutaneous injection daily (cats); animals 12 males and 12 females (crossbred cats).
The objectives of this study were to determine the toxicological effects of increasing doses of METACAM (meloxicam) 5 mg/mL Solution for Injection administered to cats. 2) Test Animals: Twenty-four crossbred cats, 12 males and 12 females were used in this study.
| Finding | Quote |
|---|---|
| Loose stools (2/6 controls, 2/6 5X) and vomiting (1/6 controls, 2/6 5X) | Loose stools were observed in four cats (2/6 controls and 2/6 5X cats). Vomiting was detected in three cats (1/6 controls and 2/6 5X cats). |
| Decreased total protein (1/6 1X, 2/6 3X, 1/6 5X) and increased BUN/creatinine in 2/6 5X cats | Serum chemistry changes observed included decreased total protein in four of 24 cats (1/6 1X, 2/6 3X, and 1/6 5X cats) and concomitant increases in BUN and creatinine values in 2/6 5X cats. |
| Jejunal mucosal erosions in 2/6 5X cats; slight GALT erosions in 1/6 3X | Mucosal erosions of the jejunum were noted in 2/6 5X cats, and slight mucosal erosions of GALT tissue of the jejunum in 1/6 3X cats. |
| Minimal to slight renal papillary necrosis in 5/6 5X cats | Microscopic renal pathology re vealed minimal to slight renal papillary necrosis (tip of the papilla) in 5/6 5X cats. |
| Conclusion: 1X tolerated; 3X and 5X produced GI and renal histologic changes | Cats receiving doses of 0.9 (3X) and 1.5 (5X) mg/kg/day showed histological changes of the gastrointestinal tract and kidneys. |
| Separate 10-day tolerance study (SC then oral daily at 0.3 or 0.6 mg/kg): severe adverse effects including death | Meloxicam, when initially dosed as a subcutaneous injection followed by oral dosing for nine days at ≥ 0.3 mg/kg was associated with severe adverse effects, including death. |
Effectiveness
Multi-site (4 clinics) active-controlled field study in client-owned cats undergoing onychectomy with or without surgical neutering; single SC meloxicam 0.3 mg/kg vs butorphanol 0.4 mg/kg before surgery; non-inferiority analysis (Study 635-0986-98F-164); n = 72 cats meloxicam, 66 cats butorphanol; primary endpoint: Occurrence of pain intervention (rescue butorphanol) in the 0-24 hour post-surgical period; result: Meloxicam non-inferior to butorphanol: 66.7% vs 71.2% of cats received one or more interventions; upper 95% bound of difference 8.7%; median interventions 1 vs 2 per cat
Forty-eight of the 72 cats in the meloxicam group received one or more interventions (66.7%), and 47 of the 66 cats in the butorphanol group received one or more interventions (71.2%).
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Elevated serum BUN post-treatment (cats) | 8.3% | none of 66 | Six cats (8.3%) in the meloxicam treatment group experienced post-treatment elevated serum blood urea nitrogen (BUN) levels. The pre-treatment values were in the normal range. Of the 66 cats in the butorphanol treatment group, no cats experienced post-treatment elevated serum blood urea nitrogen levels. |
| Post-treatment anemia (HCT < 24% and/or Hg < 8.0 g/dL) (cats) | 9 (12.5%) | 4 (6.1%) | Meloxicam Butorphanol 9/12.5%1 4/6.1% |
| Severe pain on injection (score 4) (cats) | 2.8% | 22.7% | Additionally, more cats in the butorphanol group experienced severe pain (injection score of “4”) than in the meloxicam group (22.7% in the butorphanol group compared with 2.8% in the meloxicam group). |
| Injection site pain on palpation at 24 h (cats) | one cat | none | Twenty-four hours after the injection with meloxicam, one cat experienced pain upon palpation of the injection site. No cats in the butorphanol treatment group experienced any pain on injection 24 hours after the injection. |
Extraction notes: CAVEAT: although catalogued in the dog FOI set, this Oct 28, 2004 supplement adds a FELINE indication; every study in it (PK, field study, both TAS studies) is in cats. The dog OA indication is only restated in the indication field. 'n_dogs' therefore holds cat counts. PK Table 1 prints Cmax units as 'mcg x hr/mL' and omits the Tmax unit; values copied as printed. The finding quote 'Microscopic renal pathology re vealed' preserves a PDF word split. Adverse reactions are from narrative and Table 14 (no single AR table).
Meloxicam Solution for Injection NADA 200-540, Original approval, September 21, 2014; sponsor Dechra Veterinary Products LLC; species: Dogs and cats; foi_id 1227; FDA PDF
Indication
Dogs: control of pain and inflammation associated with osteoarthritis. Cats: control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery.
Dose regimen
0.09 mg/lb (0.2 mg/kg) single dose, then 0.045 mg/lb (0.1 mg/kg) oral suspension daily (dogs), subcutaneous or intravenous injection (dogs); subcutaneous (cats), single injection, followed after 24 hours by once-daily oral suspension (dogs), Cats: single, one-time subcutaneous dose of 0.14 mg/lb (0.3 mg/kg); additional meloxicam or other NSAIDs contraindicated
Dogs: Meloxicam Solution for Injection should be administered initially as a single dose at 0.09 mg/lb (0.2 mg/kg) body weight intravenously (IV) or subcutaneously (SQ), followed, after 24 hours, by meloxicam oral suspension at the daily dose of 0.045 mg/lb (0.1 mg/kg) body weight, either mixed with food or placed directly in the mouth.
Extraction notes: Generic (ANADA) of METACAM 5 mg/mL Solution for Injection (NADA 141-219). Waiver from demonstrating bioequivalence granted on formulation characteristics. No effectiveness, target animal safety or PK studies in the summary ('CVM did not require effectiveness studies for this approval'). Summary covers dogs and cats; dog dosage recorded in dose_regimen.
Reproduce: foi_structured_search(query="meloxicam") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).