firocoxib: what the FDA reviewed for dog products
8 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing firocoxib, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Firocoxib (NADA/ANADA 200-755)
- Firocoxib Chewable Tablets (NADA/ANADA 200-861)
- Firocoxib Chewable Tablets for Dogs (NADA/ANADA 200-751)
- Firodyl™ (NADA/ANADA 200-756)
- Firox™ (NADA/ANADA 200-722)
- Previcox® (NADA/ANADA 141-230)
Firocoxib NADA 200-755, Original approval, August 03, 2023; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs; foi_id 14442; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis and control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs.
Dose regimen
2.27 mg/lb (5.0 mg/kg) body weight, Oral, Once daily, As needed for osteoarthritis; for 3 days as needed for postoperative pain associated with soft-tissue and orthopedic surgery (about two hours prior to surgery); with or without food
The recommended dosage of Firocoxib for oral administration in dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 10510 ng/mL*hour (generic) vs 9781 (RLNAD) geometric mean; ratio 1.075, 90% CI 0.973-1.187 | Single 57 mg chewable tablet, 32 fasted intact male beagles, 4-period 2-sequence crossover (Table II.1; columns generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI) | Lower 90% CI Upper 90% CI AUC (ng/mL)*hour 10510† 9781† 1.075 0.973 1.187 |
| cmax | 797 ng/mL (generic) vs 736 (RLNAD) geometric mean; ratio 1.083; sWR 0.3330; RSABE upper bound -0.0422 | Single 57 mg chewable tablet, fasted dogs (Table II.2; columns sWR, generic mean, RLNAD mean, ratio, upper 95% bound) | CMAX (ng/mL) 0.3330 797† 736† 1.083 -0.0422 |
| tmax | 3.49 hours (SD 4.75) generic vs 4.29 hours (SD 5.35) RLNAD, arithmetic mean | Single 57 mg chewable tablet, fasted dogs (Table II.2) | TMAX (hours) (SD)‡ NE 3.49 (4.75)‡ 4.29 (5.35)‡ NE NE |
| other | Dissolution similarity factor = 69.897 (57 mg vs 227 mg generic) and 54.402 (57 mg generic vs 57 mg RLNAD) | In vitro biowaiver for the 227 mg strength; USP Type 2 paddle, 0.1N HCl with 0.5% SLS, 75 rpm (Table II.3) | 57 mg generic to the 227 mg generic 69.897 57 mg generic to the 57 mg RLNAD 54.402 |
Effectiveness
Bioequivalence (blood-level) study, not a clinical effectiveness study: randomized, masked, four-period, two-sequence, single-dose crossover of generic vs Previcox 57 mg chewable tablets in fasted dogs (Study FIRH-KC2-4421), mixed reference-scaled average bioequivalence analysis; n = 32; primary endpoint: CMAX and AUC (90% CI of geometric mean ratio within 0.80-1.25 for AUC; RSABE criteria for CMAX); result: Bioequivalence demonstrated between generic and RLNAD 57 mg tablets; biowaiver granted for 227 mg strength based on dissolution
The laboratory study was conducted as a randomized, masked four-period, two- sequence, two-treatment, single-dose crossover design using 32 dogs with a 7-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) approval; no effectiveness or target animal safety studies were required. The 'effectiveness' entry is the pivotal blood-level bioequivalence study. PK values are geometric means for the generic and RLNAD (Previcox) products from flattened table rows; column order given in conditions. Dose regimen quote ends at a page break in the source text.
Firodyl™ NADA 200-756, Original approval, August 03, 2023; sponsor ZyVet Animal Health, Inc.; species: Dogs; foi_id 14443; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis and control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs.
Dose regimen
2.27 mg/lb (5.0 mg/kg) body weight, Oral, Once daily, As needed for osteoarthritis; for 3 days as needed for postoperative pain (about two hours prior to surgery); with or without food; lowest effective dose for the shortest duration
The recommended dosage of Firodyl™ (firocoxib) for oral administration in dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 18324 ng/mL*hour (generic) vs 20978 (RLNAD) geometric mean; ratio 0.87, 90% CI 0.85-0.90 | Single 57 mg chewable tablet, 24 fed intact male beagles, 2-period 2-sequence crossover (Table II.1; columns generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI) | Lower 90% CI Upper 90% CI AUC (ng/mL)*hour 18324† 20978† 0.87 0.85 0.90 |
| cmax | 1863 ng/mL (generic) vs 2184 (RLNAD) geometric mean; ratio 0.85, 90% CI 0.82-0.88 | Single 57 mg chewable tablet, fed dogs (Table II.1) | Upper 90% CI AUC (ng/mL)*hour 18324† 20978† 0.87 0.85 0.90 CMAX (ng/mL) 1863† 2184† 0.85 0.82 0.88 |
| tmax | 1.44 hours (SD 0.3) generic vs 1.51 hours (SD 0.06) RLNAD, arithmetic mean | Single 57 mg chewable tablet, fed dogs (Table II.1) | TMAX (hours) (SD)‡ 1.44 (0.3)‡ 1.51 (0.06)‡ |
| other | Dissolution similarity factor = 59.3 (57 mg vs 227 mg generic chewable tablets) | In vitro biowaiver for the 227 mg strength; USP Apparatus II, 0.5% SLS in water, 75 rpm (Table II.2) | 57 mg generic to the 227 mg chewable tablets 59.3 |
Effectiveness
Bioequivalence (blood-level) study, not a clinical effectiveness study: randomized, masked, two-period, two-sequence, single-dose crossover of generic vs Previcox 57 mg chewable tablets in fed dogs (Study 03-BQ-C-2004), average bioequivalence analysis; 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 57 mg tablets; biowaiver granted for 227 mg strength based on dissolution
The laboratory study was conducted as a randomized, masked two-period, two-sequence, two-treatment, single-dose crossover design using 24 healthy male dogs with a 7-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) approval; no effectiveness or target animal safety studies were required. The 'effectiveness' entry is the pivotal blood-level bioequivalence study in fed dogs. PK values are geometric means from a flattened table (column order in conditions); the CMAX quote spans the AUC row to capture the '90% CI' header.
Previcox® NADA 141-230, Supplemental approval, December 18, 2007; sponsor Boehringer lngelheim Animal Health USA, Inc.; species: Dogs; foi_id 769; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis and control of postoperative pain and inflammation associated with soft-tissue surgery in dogs (this supplement adds the soft-tissue surgery indication).
Dose regimen
2.27 mg/lb (5.0 mg/kg) body weight, Oral, Once daily, As needed for osteoarthritis; for 3 days as needed for postoperative pain (first dose approximately two hours prior to surgery); with or without food
The recommended dosage of PREVICOX (firocoxib) for oral administration in dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue surgery.
Effectiveness
Negative-controlled (sham-dosed), double-blinded, multi-center field study (11 sites in France, Germany, Italy and USA) in 258 client-owned dogs undergoing abdominal or major external soft-tissue surgery; firocoxib 5.0 mg/kg PO about 2 h before surgery then once daily through Day 2 plus standard of care vs standard of care alone; n = 126 firocoxib and 128 control (effectiveness analysis); primary endpoint: Success/failure defined by need for rescue analgesia (Glasgow Composite Pain Scale score of 8 or more, or investigator judgement); result: 6.4% of firocoxib dogs vs 24.2% of control dogs needed rescue (p = 0.006); mean GCPS scores lower in the firocoxib group at every assessment (p < 0.05)
Two hundred fifty-four dogs were included in the effectiveness analysis. The treatments were statistically significantly different (p = 0.006 from the generalized mixed model) with respect to the success/failure variable used as the definition of effectiveness. Eight out of 126 (6.40%) firocoxib-treated dogs and 31 out of 128 (24.2%) control dogs needed rescue medication, as shown in Table 1.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Any adverse reaction | 6.3% (n = 127) | 10 (7.6%) (n = 131) | Eight dogs (6.3%) in the firocoxib group (n = 127) experienced at least one adverse reaction compared with 10 dogs (7.6%) in the control group (n = 131), as shown in Table 2. |
| Vomiting (Table 2; columns firocoxib n (%), control n (%)) | 5 (3.94%) | 6 (4.58%) | Vomiting 5 (3.94%) 6 (4.58%) |
| Diarrhea (Table 2) | 1 (0.79%) | 1 (0.76%) | Diarrhea 1 (0.79%) 1 (0.76%) |
| Bruising at surgery site (Table 2) | 1 (0.79%) | 1 (0.76%) | Bruising at Surgery Site 1 (0.79%) 1 (0.76%) |
| Respiratory arrest (Table 2) | 1 (0.79%) | 0 (0.0%) | Respiratory Arrest 1 (0.79%) 0 (0.0%) |
| Gastric dilatation (Table 2) | 0 (0.0%) | 1 (0.76%) | Gastric Dilatation 0 (0.0%) 1 (0.76%) |
Extraction notes: Supplemental approval (2007) adding the soft-tissue surgery indication. One pivotal field study; dosage characterization and target animal safety are cross-referenced to the original 2004 NADA 141-230 approval (safety section is a short cross-reference and was not extracted). n_dogs given as group sizes because the total (254) appears only as words in the quote. No PK data. Additional Table 2 rows (SQ crepitus, swollen paw, puffy eyelids, SQ hemorrhage, suture site edema, facial edema, decompensated dilated cardiomyopathy; each 1 dog) omitted.
Previcox® NADA 141-230, Original approval, July 21, 2004; sponsor Boehringer lngelheim Animal Health USA, Inc.; species: Dogs; foi_id 768; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis in dogs.
Dose regimen
5.0 mg/kg (2.27 mg/lb), oral, once daily, Tablets scored; dosage calculated in half-tablet increments. Field studies dosed for 30 days.
A once daily oral dose of 5.0 mg/kg (2.27 mg/lb) body weight was selected based on the results of studies conducted in an experimental arthritis model.
Target-animal safety
dose multiples 1X, 3X, 5X; duration Six months (180 days); animals 16 male and 16 female (eight dogs per group).
Thirty-two Beagle dogs (16 male and 16 female, ranging in weight from 7.70 to 14.75 kg, and in age from 7 to 10.9 months) were randomly assigned to four treatment groups (eight dogs per group).
| Finding | Quote |
|---|---|
| One 3X dog diagnosed with juvenile polyarteritis of unknown etiology. | One dog in the 3X dose group was diagnosed with juvenile polyarteritis of unknown etiology after exhibiting episodes of vomiting and diarrhea, lethargy, pain, anorexia, ataxia, and proprioceptive deficits. |
| Decreased appetite, vomiting and diarrhea in all groups including controls; vomiting/diarrhea more often at 5X. | Decreased appetite/anorexia, vomiting, and diarrhea were seen in all dogs in all dose groups, including unmedicated controls, although vomiting and diarrhea were seen more often in dogs in the 5X dose group. |
| Mild ileal ulcer and focal cardiac hemorrhage in one 5X dog. | On histopathologic examination, a mild ileal ulcer and a focal hemorrhage in the heart was found in one 5X dog. |
| Mean ALP within reference range but significantly greater in 3X and 5X groups. | Mean ALP was within the normal reference range for all groups, but was statistically significantly greater in the 3X (p = 0.0269) and 5X (p = 0.0816) dose groups than in the control group. |
| Conclusion: no clinically significant adverse events at 1X for 180 days; transient hypoalbuminemia, leukocytosis and ALP elevation at higher doses. | Dogs administered firocoxib once daily at the recommended dose for 180 days showed no clinically significant adverse events. At higher doses, transient hypoalbuminemia, leukocytosis, and elevations in ALP were reported. |
| Puppy study (PR&D 0054101, dogs <7 months): subclinical periportal hepatic fatty change at 5 mg/kg; deaths/euthanasia at 3X and 5X. | At 5 mg/kg, firocoxib treatment was associated with subclinical periportal hepatic fatty change in puppies less than seven months of age. At higher dose groups in this age dog, duodenal ulceration, hepatic fatty change, decreased weight gain, and decreased serum albumin were observed. |
Effectiveness
Two active-controlled, masked, randomized field studies (PR&D 00535 and 00538, 5 sites): firocoxib 5.0 mg/kg orally once daily vs etodolac 10-15 mg/kg once daily for 30 days; non-inferiority analysis (15% margin) of veterinary clinical improvement at Day 14 and Day 29.; n = 121 firocoxib, 118 active control evaluated; primary endpoint: Percentage of dogs with overall veterinary clinical improvement at study end (reduction of at least 1 grade in lameness and/or combined 2-grade reduction in pain on palpation, range of motion and joint swelling).; result: Overall veterinary clinical improvement Day 29: 87.6% firocoxib vs 83.1% etodolac (difference 3.8%, lower confidence bound -3.9%); Day 14: 80.2% vs 78.8%; non-inferiority demonstrated. Force-plate peak vertical force improvement 14.1% vs 12.7% (non-inferior).
Firocoxib 80.2% (97/121*) 87.6% (106/121) Active Control 78.8% (93/118) 83.1% (98/118)
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 5/128 | 8/121 | Adverse Reactions* Firocoxib n=128** Active Control n=121** Vomiting 5 8 Decreased food consumption/Anorexia 3 3 Pain 2 1 Diarrhea 1 10 Lethargy 1 3 |
| Decreased food consumption/Anorexia | 3/128 | 3/121 | Adverse Reactions* Firocoxib n=128** Active Control n=121** Vomiting 5 8 Decreased food consumption/Anorexia 3 3 Pain 2 1 Diarrhea 1 10 Lethargy 1 3 |
| Pain | 2/128 | 1/121 | Adverse Reactions* Firocoxib n=128** Active Control n=121** Vomiting 5 8 Decreased food consumption/Anorexia 3 3 Pain 2 1 Diarrhea 1 10 Lethargy 1 3 |
| Diarrhea | 1/128 | 10/121 | Adverse Reactions* Firocoxib n=128** Active Control n=121** Vomiting 5 8 Decreased food consumption/Anorexia 3 3 Pain 2 1 Diarrhea 1 10 Lethargy 1 3 |
| Lethargy | 1/128 | 3/121 | Adverse Reactions* Firocoxib n=128** Active Control n=121** Vomiting 5 8 Decreased food consumption/Anorexia 3 3 Pain 2 1 Diarrhea 1 10 Lethargy 1 3 |
Extraction notes: No numeric pharmacokinetic parameters in this summary (only that plasma firocoxib 'increased with dose, and were approximately proportional to dose'). The active control in the field studies was etodolac (EtoGesic), not placebo. Target animal safety uses the six-month 1X/3X/5X study in dogs 7-10.9 months old (PR&D 0078601); the summary also reports a six-month study in 10-13-week-old puppies (PR&D 0054101) with one death and four euthanasias at 3X/5X and a 10X (>50 mg/kg) 22-day study with small intestinal erosion/ulceration in 3 of 4 dogs. Adverse-reaction counts are dogs from Table 5 (n=128 firocoxib, n=121 active control). The label 'k. Recommended Dosage' text (2.2 mg/lb) is split by a layout artifact, so the dose quote is taken from the dosage characterization section.
Firocoxib Chewable Tablets NADA 200-861, Original approval, July 21, 2026; sponsor Ajenat Pharmaceuticals LLC; species: Dogs; foi_id 18679; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis and control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs.
Dose regimen
2.27 mg/lb (5.0 mg/kg) body weight, Oral, Once daily, As needed for osteoarthritis; for 3 days as needed for postoperative pain (about two hours prior to surgery); with or without food; lowest effective dose for the shortest duration
The recommended dosage of Firocoxib Chewable Tablets for oral administration in dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft- tissue and orthopedic surgery.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 7702.50 ng/mL*hour (generic) vs 7830.64 (RLNAD) geometric mean; ratio 0.98; CI 0.91-1.06; sWR 0.24 | Single 57 mg chewable tablet, 40 fasted male and female dogs, 4-period 2-sequence crossover (Table II.1; columns sWR, generic mean, RLNAD mean, ratio, 95% upper bound, 90% CI for the ratio) | AUC (ng/mL)*hour 0.24 7702.50† 7830.64† 0.98 NE (0.91, 1.06) |
| cmax | 652.62 ng/mL (generic) vs 668.48 (RLNAD) geometric mean; ratio 0.97; sWR 0.37; RSABE upper bound -0.07 | Single 57 mg chewable tablet, fasted dogs (Table II.1; same column order) | CMAX (ng/mL) 0.37 652.62† 668.48† 0.97 -0.07 NE |
| tmax | 1.53 hours (SD 0.86) generic vs 1.87 hours (SD 0.82) RLNAD, arithmetic mean | Single 57 mg chewable tablet, fasted dogs (Table II.1) | TMAX (hours) (SD‡) NE 1.53 (0.86)‡ 1.87 (0.82)‡ NE NE NE |
| other | Dissolution similarity factor = 89.9 (57 mg vs 227 mg generic) | In vitro biowaiver for the 227 mg strength; USP Apparatus II, 50 rpm, acetate buffer + 1% cetrimide pH 4.5 (Table II.2) | 57 mg generic chewable tablets to the 227 mg chewable tablets 89.9 |
| other | Dissolution similarity factor = 56.3 (57 mg generic vs 57 mg RLNAD) and 54.7 (227 mg generic vs 227 mg RLNAD) | In vitro comparison with RLNAD strengths (Table II.2) | 57 mg generic chewable tablets to the 57 mg RLNAD chewable tablets 56.3 227 mg generic chewable tablets to the 227 mg RLNAD chewable tablets 54.7 |
Effectiveness
Bioequivalence (blood-level) study, not a clinical effectiveness study: randomized, masked, four-period, two-sequence, single-dose crossover of generic vs Previcox 57 mg chewable tablets in fasted dogs (Study 023-01925), mixed reference-scaled average bioequivalence analysis; n = 40; primary endpoint: CMAX and AUC (average bioequivalence for AUC, RSABE for CMAX); result: Bioequivalence demonstrated between generic and RLNAD 57 mg tablets; biowaiver granted for 227 mg strength based on dissolution
The laboratory study was conducted as a randomized, masked, four-period, two- sequence, two-treatment, single-dose crossover design using 40 dogs with a 7-day washout between periods 1 and 2, and periods 3 and 4, and a 14-day washout period between periods 2 and 3.
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) approval (2026); no effectiveness or target animal safety studies were required. The 'effectiveness' entry is the pivotal blood-level bioequivalence study. PK values are geometric means from a flattened table; the AUC 90% CI is written 'CI 0.91-1.06' because the '90%' header is not in the quoted row. Hyphenation artefacts ('soft- tissue', 'two- sequence') are reproduced verbatim from the source text.
Firocoxib Chewable Tablets for Dogs NADA 200-751, Original approval, June 22, 2023; sponsor Pegasus Laboratories, Inc.; species: Dogs; foi_id 14173; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis, and control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs.
Dose regimen
2.27 mg/lb (5.0 mg/kg), oral (chewable tablet), with or without food, once daily, as needed for osteoarthritis; for 3 days as needed for postoperative pain (may be given about two hours before surgery)
The recommended dosage of Firocoxib Chewable Tablets for Dogs (firocoxib) for oral administration in dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 14248 (ng/mL)*hour generic; 13949 (ng/mL)*hour Previcox (geometric means) | single oral 57 mg tablet, 30 female Beagles (9.7-12.9 kg), two-period crossover (Study PLI-CL047) | AUC (ng/mL)*hour 14248† 13949† 1.02 0.94 1.11 |
| cmax | 1555 ng/mL generic; 1574 ng/mL Previcox (geometric means) | single oral 57 mg tablet, 30 female Beagles, crossover | CMAX (ng/mL) 1555† 1574† 0.99 0.85 1.15 |
| tmax | 2.26 hours (SD 1.94) generic; 1.98 hours (SD 1.86) Previcox (arithmetic means) | single oral 57 mg tablet, 30 female Beagles, crossover | TMAX (hours) (SD)‡ 2.26 (1.94)‡ 1.98 (1.86)‡ NE NE NE |
Extraction notes: ANADA (generic): no effectiveness or target animal safety studies were required; approval rests on a blood-level bioequivalence study of the 57 mg tablet vs Previcox (AUC ratio 1.02, 90% CI 0.94-1.11; Cmax ratio 0.99, 90% CI 0.85-1.15; both within 0.80-1.25) and a dissolution biowaiver for the 227 mg tablet (f2 = 63). No serious adverse events in the BE study; no adverse-reaction table exists.
Firox™ NADA 200-722, Original approval, March 28, 2022; sponsor Norbrook Laboratories, Ltd.; species: Dogs; foi_id 12172; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis and control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs.
Dose regimen
2.27 mg/lb (5.0 mg/kg), oral, once daily, As needed for osteoarthritis; 3 days as needed for postoperative pain (may be given about two hours before surgery); with or without food; half-tablet increments.
The recommended dosage of Firox™ (firocoxib) for oral administration in dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as needed for osteoarthritis
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 10.91 (µg/mL)*hour (geometric mean, generic) | single 57 mg tablet, 40 healthy fasted beagles, four-period crossover; RLNAD Previcox 10.38; ratio 1.050 (90% CI 0.975-1.132) | AUC (µg/mL)*hour 10.91† 10.38† 1.050 0.975 1.132 |
| cmax | 0.79 µg/mL (geometric mean, generic) | single 57 mg tablet, 40 fasted beagles; RLNAD 0.77; ratio 1.056 (90% CI 0.951-1.172) | CMAX (µg/mL) 0.79† 0.77† 1.056 0.951 1.172 |
| tmax | 2.88 hours (SD 4.35), generic | single 57 mg tablet, 40 fasted beagles; RLNAD 2.50 (3.59); arithmetic mean | TMAX (hours) (SD)‡ 2.88 (4.35)‡ 2.50 (3.59)‡ NE NE NE |
Extraction notes: Generic (ANADA) approval; the summary has no effectiveness or target animal safety sections ('The FD&C Act doesn't require the sponsor to submit new effectiveness or target animal safety data'). PK values are from the single in vivo blood-level bioequivalence study (Study 026/18, randomized masked four-period two-sequence crossover, 21-day washout) versus Previcox 57 mg; 'There were no serious adverse events reported during the study.' Biowaiver granted for the 227 mg strength (f2 = 57.4). The trademark symbol in quotes is the source's '™' character.
Previcox® NADA 141-230, Supplemental approval, September 23, 2008; sponsor Boehringer lngelheim Animal Health USA, Inc.; species: Dogs; foi_id 770; FDA PDF
Indication
Control of pain and inflammation associated with osteoarthritis and control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs (this supplement adds the orthopedic surgery indication).
Dose regimen
2.27 mg/lb (5.0 mg/kg) body weight, Oral, Once daily, As needed for osteoarthritis; for 3 days as needed for postoperative pain (first dose approximately two hours prior to surgery); use the lowest effective dose for the shortest period
The recommended dosage of PREVICOX (firocoxib) for oral administration in dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery.
Effectiveness
Double-blinded, multi-center (12 sites, USA and Europe) add-on field study with rescue: firocoxib 5.0 mg/kg PO about 2 h before surgery then once daily through Day 2 plus standard of care vs sham-dosed standard of care in dogs undergoing arthrotomy and joint stabilization (fabellar suture, fibular head transposition, TPLO, over-the-top); n = 220 (116 PREVICOX, 104 control) in the effectiveness database; 226 in the safety database; primary endpoint: Success/failure based on completion of the study without rescue analgesia (GCPS score of 8 or more or investigator judgement); result: Treatment failures 11.2% PREVICOX vs 37.5% control (p = 0.0050); least squares mean GCPS total scores lower with firocoxib (p < 0.05)
Two hundred twenty dogs (220) were included in the effectiveness database (116 PREVICOX cases). A total of 226 dogs were included in the field safety database (118 PREVICOX cases). The difference between treatments was significantly different (p = 0.0050) with respect to the success/failure variable used as the definition of effectiveness. Thirteen of the 116 (11.2%) PREVICOX-treated cases and 39 out of 104 (37.5%) control dogs were treatment failures, as shown in Table 1.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Incision swelling, redness (Table 2; columns firocoxib n=118, control n=108) | 9 | 5 | incision swelling, redness 9 5 |
| Bruising at surgery site (Table 2) | 2 | 3 | bruising at surgery site 2 3 |
| Diarrhea (Table 2; 'b' footnote: one dog had hemorrhagic gastroenteritis) | 2 | 1 | diarrhea 2 b 1 |
| Oozing incision (Table 2) | 2 | 0 | oozing incision 2 0 |
| Inappetance/decreased appetite (Table 2) | 1 | 2 | inappetance/decreased appetite 1 2 |
| Vomiting (Table 2) | 1 | 0 | vomiting 1 0 |
Extraction notes: Supplemental approval (2008) adding the orthopedic surgery indication. One pivotal field study; dosage characterization and target animal safety cross-referenced to the original 2004 approval (safety section is a short cross-reference, not extracted). Six PREVICOX cases and one control case had normal pre- and elevated post-study BUN. Table 2 gives counts only (no percentages); pyrexia (0 vs 1) omitted. No PK data.
Reproduce: foi_structured_search(query="firocoxib") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).