Deracoxib: what the FDA reviewed for dog products
7 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Deracoxib, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs; dogs.
Products
- Deracoxib Chewable Tablets (NADA/ANADA 200-704)
- Deramaxx® Chewable Tablets (NADA/ANADA 141-203)
- Doxidyl™ (NADA/ANADA 200-637)
Deramaxx® Chewable Tablets NADA 141-203, Original approval, August 21, 2002; sponsor Elanco US Inc.; species: dogs; foi_id 717; FDA PDF
Indication
Control of postoperative pain and inflammation associated with orthopedic surgery in dogs > 4 lbs (1.8 kg).
Dose regimen
3-4 mg/kg/day (1.4 to 1.8 mg/lb/day), oral, single daily dose, as needed for 7 days; tablets scored, dose calculated in half-tablet increments
The recommended daily dose of DERAMAXX tablets for postoperative orthopedic pain is 3-4 mg/kg/day (1.4 to 1.8 mg/lb/day) as a single daily dose, as needed for 7 days.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | nonlinear elimination at doses > 10 mg/kg/day (greater than dose-proportional plasma levels) | two-week PK/toxicity study, micronized deracoxib in gelatin capsules, 10-100 mg/kg/day orally to fasted Beagles | data collected in the study indicates that nonlinear elimination occurs with deracoxib at doses > 10 mg/kg/day. |
| other | plasma concentrations approximately proportional to dose over the dose range studied | 13-week capsule study, 0/2/4/8 mg/kg/day oral, Beagles (3 dogs/sex/dose in PK portion) | Plasma concentrations increased with dose and were approximately proportional to dose over the dose range studied. |
Target-animal safety
dose multiples 0, 4, 6, 8, 10 mg/kg body weight/day (21-day study, final market tablet, ~1X to 2.5X of 4 mg/kg); duration Twenty-one days; animals Forty (20 male and 20 female), four per sex per group.
Test animals: Forty Beagle dogs (20 male and 20 female, 4-6 months of age, 6-9 kg body weight); four dogs per sex per treatment
| Finding | Quote |
|---|---|
| Dose groups 0, 4, 6, 8, 10 mg/kg/day for 21 days | Dosage used: 0, 4, 6, 8, 10 mg/kg body weight/day g. Test duration: Twenty-one days |
| All dogs survived; no adverse drug events | All dogs survived to study termination. No adverse drug events were reported. |
| Dose-related increase in BUN at all doses (mean BUN within reference range at labelled dose) | There was a dose-related increase in BUN values associated with administration of deracoxib tablets at all doses. |
| Trace renal tubular degeneration/regeneration in all groups including placebo | Renal histopathology revealed trace amounts of tubular degeneration/regeneration in all dose groups including placebo. |
| No toxicity at doses < 8 mg/kg once daily for 21 days (given within 30 minutes of feeding) | did not produce toxicity at doses < 8 mg/kg once daily for 21 days |
| Two-week capsule study (10-100 mg/kg/day): gastric ulcers and small-intestinal erosions/ulcers in all dogs at 100 mg/kg | At 100 mg/kg all dogs exhibited gastric ulcers and erosions/ulcerations of the small intestines. |
| Two-week capsule study: no-effect level less than 10 mg/kg | The no effect dose level for micronized deracoxib administered once daily in gelatin capsules is less than 10 mg/kg. |
Effectiveness
Placebo-controlled, masked, randomized field study at 6 US veterinary clinics in dogs undergoing cranial cruciate ligament repair; 3-4 mg/kg orally the evening before surgery then once daily for 6 days (7 days total); single rescue dose of butorphanol allowed; n = 119 in effectiveness analysis; primary endpoint: Lameness at a walk, lameness at a trot, pain on palpation of the stifle (Days 2, 3, 4, 7) and need for additional postoperative analgesia; result: Statistically significant differences (p<0.05) favored deracoxib at all postoperative evaluations for lameness at walk, lameness at trot and pain on palpation; 2 placebo vs 1 deracoxib dog required analgesia beyond a single butorphanol injection
d. Results: One hundred and nineteen (119) dogs were included in the overall effectiveness analysis.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 11 | 6 | Vomiting 11 6 Diarrhea 6 7 Hematochezia 4 0 |
| Diarrhea | 6 | 7 | Vomiting 11 6 Diarrhea 6 7 Hematochezia 4 0 |
| Hematochezia | 4 | 0 | Hematochezia 4 0 Melena 0 1 Anorexia 0 4 |
| Anorexia | 0 | 4 | Hematochezia 4 0 Melena 0 1 Anorexia 0 4 |
| Incision site lesion (drainage, oozing) | 11 | 6 | Incision site lesion (drainage, oozing) 11 6 |
| Death | 0 | 1 | Splenomegaly 1 0 Hepatomegaly 1 0 Death 0 1 |
Extraction notes: Original approval; text has no parsed sections (raw text used) and many PDF-broken words, so quotes were chosen to avoid them. Field study: 207 client-owned dogs enrolled (105 deracoxib / 102 placebo in safety evaluation; 59 deracoxib / 60 placebo evaluated for effectiveness per design section, 119 in results). Adverse reaction table columns: DERAMAXX tablets N = 105 | Placebo N = 102 (counts of dogs). TAS: three lab studies (2-week capsule PK/toxicity 10-100 mg/kg, 21-day market-tablet 0-10 mg/kg, 13-week capsule 0-8 mg/kg); the 21-day study is recorded as the main TAS entry; no dose multiples are stated in the summary. No numeric PK parameters reported.
Doxidyl™ NADA 200-637, Original approval, February 04, 2019; sponsor Ceva Sante Animale; species: Dogs; foi_id 6787; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis; control of postoperative pain and inflammation associated with orthopedic surgery; and with dental surgery in dogs.
Dose regimen
0.45-0.91 mg/lb/day (1 to 2 mg/kg/day), oral, single daily dose, as needed, Osteoarthritis regimen shown; postoperative orthopedic 3 to 4 mg/kg/day not to exceed 7 days; postoperative dental 1 to 2 mg/kg/day for 3 days with first dose about 1 hour before surgery.
Osteoarthritis Pain and Inflammation: 0.45-0.91 mg/lb/day (1 to 2 mg/kg/day) as a single dose, as needed.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 7807.97 ppm*h (geometric mean, test) | single 25 mg generic deracoxib chewable tablet, 24 healthy intact female beagles, two-period crossover; reference Deramaxx 7809.53; ratio 99.98% (90% CI 88.79-112.58) | AUC (ppm*h) 7807.97† 7809.53† 99.98 88.79 112.58 |
| cmax | 908.78 ppm (geometric mean, test) | single 25 mg generic tablet, n=24 female beagles; reference 911.51; ratio 99.70% (90% CI 86.66-114.70) | CMAX (ppm) 908.78† 911.51† 99.70 86.66 114.70 |
| tmax | 1.98 h (arithmetic mean, test) | single 25 mg generic tablet, n=24 female beagles; reference 2.08 h | TMAX (h) 1.98‡ 2.08‡ NE NE NE |
Extraction notes: Generic (ANADA) approval: 'CVM did not require effectiveness studies for this approval' and 'CVM did not require target animal safety studies for this approval'; safety and effectiveness rest on the RLNAD Deramaxx (NADA 141-203). Only PK data are from the in vivo blood-level bioequivalence study (SBL 017-01565, 14-day washout); 'No adverse reactions were reported in this study.' Biowaiver granted for 12, 75 and 100 mg strengths on dissolution (f2 67.5, 57.4, 60.1). The trademark symbol is rendered 'TM' in the source text.
Deramaxx® Chewable Tablets NADA 141-203, Supplemental approval, February 11, 2003; sponsor Elanco US Inc.; species: dogs; foi_id 718; FDA PDF
Indication
Adds control of pain and inflammation associated with osteoarthritis in dogs (in addition to postoperative orthopedic pain) in dogs > 4 lbs (1.8 kg).
Dose regimen
1-2 mg/kg/day (0.45-0.91 mg/lb/day), oral, single daily dose, as needed (osteoarthritis); postoperative orthopedic dose remains 3-4 mg/kg/day not to exceed 7 days
of DERAMAXX tablets for the control of pain and inflammation associated with osteoarthritis in dogs is 1-2 mg/kg/day (0.45-0.91 mg/lb/day) as a single daily dose, as needed.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | dose proportional increases in systemic drug exposure | 6-month safety study, 2-10 mg/kg/day oral tablets, Beagles (single plasma sample per dog) | Evaluation of the pharmacokinetic data demonstrated that dose proportional increases in systemic drug exposure were achieved. |
Target-animal safety
dose multiples 1X, 2X, 3X, 4X, 5X; duration Twenty-six weeks (6 months), daily; animals Sixty (30 male, 30 female), five per sex per group.
(b) Test animals: Sixty healthy Beagle dogs (30 male, 30 female, approximately 4 months of age), five per sex per treatment.
| Finding | Quote |
|---|---|
| All dogs survived; no abnormal feces, clinical observations, food/water consumption, body weights, physical exams, ophthalmoscopy, gross pathology, bone marrow, hematology or buccal bleeding time findings | (4) Results: All dogs survived to termination of the study. |
| Hyposthenuria and polyuria in one male and one female at 6 mg/kg after 6 months | Urinalysis results showed hyposthenuria (specific gravity < 1.005) and polyuria in one male and one female in the 6 mg/kg group after 6 months of treatment. |
| Mean BUN increased in the 6, 8 and 10 mg/kg/day groups after 6 months (30, 35.3, 48.2 mg/dl; reference 7-32 mg/dl) | These values were 30, 35.3, and 48.2 mg/dl respectively. |
| Focal renal papillary necrosis in 3 dogs at 10 mg/kg/day and one at 8 mg/kg/day; no GI, hepatic or hematopoietic pathology | Focal renal papillary necrosis was seen in 3 dogs dosed at 10 mg/kg/day and one dog dosed at 8 mg/kg/day. There was no evidence of gastrointestinal, hepatic or hematopoetic pathology in any of the dogs. |
| Dose-dependent focal renal tubular degeneration/regeneration at > 6 mg/kg/day | Focal renal tubular degeneration/regeneration was seen at doses > 6 mg/kg/day. |
Effectiveness
Placebo-controlled, masked, randomized multicenter field study (7 sites) in client-owned dogs with clinical and radiographic osteoarthritis; 1-2 mg/kg orally once daily for 43 days; 209 enrolled; n = 105 DERAMAXX / 104 placebo treated; primary endpoint: Force plate (vertical impulse area, peak vertical force), veterinarian lameness/pain scores and owner ratings of quality of life, lameness and activity on Days 14, 28, 42; result: Statistically significant (p<0.05) differences favoring DERAMAXX for vertical impulse area, peak vertical force and owner evaluations at most time points; no significant difference for veterinarian clinical evaluations; e.g. owner-rated quality-of-life improvement Day 42: 58/89 (65.2%) vs 35/87 (40.2%)
A total of 105 dogs were treated with DERAMAXX tablets and 104 received the placebo.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 3 | 4 | Vomiting 3 4 Diarrhea/Soft Stool 3 2 Weight Loss 1 0 |
| Diarrhea/Soft Stool | 3 | 2 | Vomiting 3 4 Diarrhea/Soft Stool 3 2 Weight Loss 1 0 |
| Weight Loss | 1 | 0 | Vomiting 3 4 Diarrhea/Soft Stool 3 2 Weight Loss 1 0 |
| Seizure | 1 | 0 | Seizure 1 0 Lethargy 0 1 Pyoderma/Dermatitis 2 0 |
| Pyoderma/Dermatitis | 2 | 0 | Seizure 1 0 Lethargy 0 1 Pyoderma/Dermatitis 2 0 |
| Splenomegaly (dog withdrawn Day 17, died 1 month after exiting study) | 1 | 0 | Hematuria/UTI 1 0 Splenomegaly* 1 0 |
Extraction notes: Supplemental approval adding the osteoarthritis claim and 1-2 mg/kg dose. Text has no parsed sections and PDF-broken words; quotes avoid them. Adverse reaction table columns: DERAMAXX n=105 | Placebo n=104. The 6-month TAS doses were 2, 4, 6, 8, 10 mg/kg/day labelled 1X-5X in the summary's Table 6 (181 dogs in effectiveness evaluation, 194 in clinical pathology, 114 with force plate data). Dosage characterization used a urate crystal synovitis model (0, 0.3, 1, 3, 10 mg/kg).
Deramaxx® Chewable Tablets NADA 141-203, Supplemental approval, June 13, 2007; sponsor Elanco US Inc.; species: Dogs; foi_id 719; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs, and control of postoperative pain and inflammation associated with orthopedic surgery in dogs > 4 lbs (1.8 kg).
Dose regimen
0.45-0.91 mg/lb/day (osteoarthritis); 1.4-1.8 mg/lb/day (3-4 mg/kg/day) (postoperative orthopedic pain), oral (tablet), single daily dose, as needed, postoperative use not to exceed 7 days
The daily dose of DERAMAXX tablets for the control of pain and inflammation associated wit osteoarthritis in dogs is 0.45-0.91 mg/lb/day (1- mg/kg/day) as a single daily dose, as needed. The dose for postoperative orthopedic pain is 1.4-1.8 mg/lb/day (3-4 mg/kg/day) as a single daily dose, as needed, not to exceed 7 days of administration.
Extraction notes: Supplemental approval (June 13, 2007) adding a 75 mg tablet size only. No new effectiveness, PK or target animal safety data: 'CVM did not require effectiveness studies for this supplemental approval' and 'CVM did not require target animal safety studies'. The osteoarthritis mg/kg dose is garbled in the PDF text ('1- mg/kg/day', the 2 is lost), so the dose field gives only the mg/lb range for OA. Indication quote truncated because the remainder is broken by stray characters in the extracted text.
Deracoxib Chewable Tablets NADA 200-704, Original approval, June 14, 2021; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs; foi_id 10943; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis, postoperative orthopedic surgery, and postoperative dental surgery in dogs.
Dose regimen
0.45-0.91 mg/lb/day (1-2 mg/kg/day) for osteoarthritis and postoperative dental pain; 1.4-1.8 mg/lb/day (3-4 mg/kg/day) for postoperative orthopedic pain, Oral, single daily dose, osteoarthritis: as needed; orthopedic: as needed, not to exceed 7 days; dental: for 3 days
Postoperative Orthopedic Pain and Inflammation: 1.4 – 1.8 mg/lb/day (3 to 4 mg/kg/day) as a single daily dose, as needed, not to exceed 7 days of administration. Postoperative Dental Pain and Inflammation: 0.45 – 0.91 mg/lb/day (1 to 2 mg/kg/day) as a single daily dose, for 3 days.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | generic/RLNAD geometric mean ratio 0.99 (sWR 0.3229; upper bound -0.0529) | 25 mg single oral dose, fasted intact female dogs, n=24, four-period crossover; reference-scaled average bioequivalence; AUC in ng*hr/mL | AUC (ng*hr/mL) 0.3229 0.99 -0.0529 |
| cmax | generic/RLNAD geometric mean ratio 1.03 (sWR 0.3973; upper bound -0.0767) | 25 mg single oral dose, fasted female dogs, n=24 crossover; CMAX in ng/mL | CMAX (ng/mL) 0.3973 1.03 -0.0767 |
| tmax | 2.3 hours (arithmetic mean, both generic and RLNAD) | 25 mg single oral dose, fasted dogs, n=24 | mean of TMAX is 2.3 hours for both generic article and RLNAD. |
Effectiveness
Blood-level bioequivalence study (not a clinical effectiveness study): randomized, masked, four-period, two-sequence, single-dose crossover of 25 mg generic vs 25 mg Deramaxx in fasted dogs, 14-day washout; biowaiver for 12, 75, 100 mg strengths based on dissolution; n = 24; primary endpoint: CMAX and AUC (mixed reference-scaled average bioequivalence); result: Bioequivalence demonstrated for the 25 mg tablet; f2 similarity 66 (75 mg) and 62 (100 mg), 12 mg >85% dissolved in 15 min
The in vivo blood-level study was conducted in 24 healthy, fasted dogs.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events (bioequivalence study) | none reported | Adverse Reactions: There were no serious adverse events reported during the study. |
Extraction notes: Generic (ANADA) approval; no effectiveness or target animal safety studies required. PK table (Table II.1) columns: Parameter | sWR (within-subject SD of RLNAD) | Ratio (generic/RLNAD geometric mean point estimate) | Upper 95% Bound of the RSABE criterion; no absolute AUC/CMAX values are reported. The dose quote uses en dashes as printed.
Deramaxx® Chewable Tablets NADA 141-203, Supplemental approval, May 16, 2008; sponsor Elanco US Inc.; species: Dogs; foi_id 720; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis, and of postoperative pain and inflammation associated with orthopedic surgery, in dogs > 4 lbs (1.8 kg).
Dose regimen
0.45-0.91 mg/lb/day (1-2 mg/kg/day) for osteoarthritis; 1.4-1.8 mg/lb/day (3-4 mg/kg/day) for postoperative orthopedic pain, Oral, single daily dose, as needed; orthopedic dose not to exceed 7 days of administration
The daily dose of DERAMAXX tablets for the control of pain and inflammation associated with osteoarthritis in dogs is 0.45-0.91 mg/lb/day (1-2 mg/kg/day) as a single daily dose, as needed. The dose for postoperative orthopedic pain is 1.4-1.8 mg/lb/day (3-4 mg/kg/day) as a single daily dose, as needed, not to exceed 7 days of administration.
Extraction notes: Supplemental approval adding a 50-mg tablet size only. 'CVM did not require effectiveness studies for this supplemental approval.' 'CVM did not require target animal safety studies for this supplemental approval.' No study content.
Deramaxx® Chewable Tablets NADA 141-203, Supplemental approval, November 23, 2011; sponsor Elanco US Inc.; species: Dogs; foi_id 721; FDA PDF
Indication
Adds control of postoperative pain and inflammation associated with dental surgery in dogs (existing claims: osteoarthritis; postoperative orthopedic surgery).
Dose regimen
0.45-0.91 mg/lb (1-2 mg/kg), Oral, once daily, for 3 days; first dose approximately 1 hour prior to dental surgery, then daily for up to two additional treatments
The effect of the supplement is the addition of a new indication for the control of postoperative pain and inflammation associated with dental surgery in dogs at a dose of 0.45-0.91 mg/lb (1-2 mg/kg) administered orally once daily for 3 days.
Effectiveness
Placebo-controlled, masked, randomized field study at 4 US sites in client-owned dogs undergoing dental extractions; 0.45-0.91 mg/lb once daily for 3 days (first dose >= 1 h before surgery); placebo = commercial vitamin tablet; all dogs premedicated with butorphanol; n = 27 DERAMAXX / 30 placebo in effectiveness evaluation (fifty-seven); 62 enrolled in safety assessment; primary endpoint: Treatment failure = need for rescue analgesia (modified Glasgow Composite Pain Scale score >= 4 or investigator judgment); result: Rescue required in 4/27 (14.81%) DERAMAXX dogs vs 20/30 (66.67%) placebo dogs; p=0.0338 in favor of DERAMAXX
Fifty-seven dogs were included in the effectiveness evaluations whereas all 62 dogs enrolled in the study were included in the safety assessment. Twenty out of 30 (66.67%) placebo control dogs were rescued during the study (treatment failures) compared to 4 out of 27 (14.81%) DERAMAXX treated dogs requiring rescue therapy. The difference in treatment success/failure outcomes was statistically significant (p=0.0338) in favor of the DERAMAXX treated group.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 4 | 1 | Vomiting 4 1 Diarrhea/Soft Stool 3 1 Regurgitation 0 2 |
| Diarrhea/Soft Stool | 3 | 1 | Vomiting 4 1 Diarrhea/Soft Stool 3 1 Regurgitation 0 2 |
| Regurgitation | 0 | 2 | Vomiting 4 1 Diarrhea/Soft Stool 3 1 Regurgitation 0 2 |
| Increased AST (results over 2x high normal) | 3 | 0 | Increased AST2 3 0 Increased ALT2 1 0 Hematuria 1 0 |
| Increased ALT (results over 2x high normal) | 1 | 0 | Increased AST2 3 0 Increased ALT2 1 0 Hematuria 1 0 |
| Lameness | 1 | 0 | Lameness 1 0 Facial Swelling 0 1 Tachycardia 0 1 |
Extraction notes: Supplemental approval (dental surgery claim). 'CVM did not require target animal safety studies for this supplemental approval.' Adverse reaction table (Table 2) columns: DERAMAXX n= 31 | Placebo n= 31; the trailing '2' in 'AST2'/'ALT2' is a footnote marker (results over 2x the high normal). Raw text contains PDF replacement characters; quotes avoid them.
Reproduce: foi_structured_search(query="Deracoxib") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).