Clindamycin Hydrochloride: what the FDA reviewed for dog products

Clindamycin Hydrochloride Oral Liquid NADA 200-193, Supplemental approval, April 21, 2004; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs and cats; foi_id 994; FDA PDF

Indication

Dogs: skin infections (wounds and abscess) due to coagulase positive staphylococci; deep wounds and abscess, dental infections and osteomyelitis due to S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum and C. perfringens. Cats: skin infections, deep wounds/abscesses and dental infections due to the listed organisms.

Dose regimen

2.5 to 15 mg/lb (wounds, abscesses, dental infections); 5.0 to 15 mg/lb (osteomyelitis) - dogs, Oral (solution, 25 mg/mL), Every 12 hours, Maximum of 28 days (wounds/abscesses/dental); minimum of 28 days (osteomyelitis). Cats: 5.0 to 15.0 mg/lb every 24 hours for a maximum of 14 days.

Dogs: Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound of body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb of body weight every 12 hours for a minimum of 28 days.

Extraction notes: Supplemental generic ANADA (Phoenix Scientific) expanding the dose range (dogs: point dose 2.5 mg/lb to 2.5-15 mg/lb; cats: 5.0-10.0 to 5.0-15.0 mg/lb) and changing 'soft tissue infections' to 'skin infections', matching the pioneer's 2002 supplement. No new studies; in vivo bioequivalence waived on formulation characteristics. Indication quote preserves the summary's typo 'Staphyloccus' and stray space before the comma.

Clindamycin Hydrochloride Capsules NADA 200-298, Supplemental approval, April 21, 2004; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 1048; FDA PDF

Indication

Treatment of skin infections (wounds and abscesses), deep wounds and abscesses, dental infections and osteomyelitis due to susceptible strains of the designated staphylococci and anaerobes in dogs.

Dose regimen

2.5 to 15 mg per pound (wounds, abscesses, dental infections); 5.0 to 15 mg/lb (osteomyelitis), Oral, every 12 hours, Maximum of 28 days for wounds, abscesses and dental infections; minimum of 28 days for osteomyelitis.

Recommended Dosage: Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound of body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb of body weight every 12 hours for a minimum of 28 days.

Extraction notes: Supplemental ANADA (2004) expanding the dosage range and adding a 300 mg capsule, mirroring pioneer Antirobe (NADA 120-161) claims. No new studies: the sponsor was granted a waiver from the in vivo bioequivalence requirement based on formulation characteristics. Indication quote copies source typos ('perfringes', 'nerophorum').

Clindamycin Hydrochloride Oral Liquid NADA 200-193, Original approval, August 01, 1997; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 1426; FDA PDF

Indication

Labeling indications identical to the pioneer Antirobe Aquadrops (NADA 135-940) for use in dogs; the summary does not restate them (catalogue: therapy of wounds, abscesses, dental infections, and osteomyelitis).

Extraction notes: Original generic ANADA (Phoenix Scientific), reformatted (Section 508) summary of two pages. No dosage regimen, indication list or studies are given. Species: 'The product is labeled for use in dogs only, not a food producing animal.' Bioequivalence established by chemical equivalence; in vivo study waived December 8, 1995 ('The generic and pioneer products are solutions with the same active and inactive ingredients.').

Clinsol® NADA 200-291, Original approval, August 26, 2002; sponsor Virbac AH, Inc.; species: Dogs and cats; foi_id 1043; FDA PDF

Indication

Dogs: soft tissue infections (wounds and abscesses), dental infections and osteomyelitis caused by susceptible Staphylococcus aureus (aerobic) and by Bacteroides fragilis, Bacteroides melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens (anaerobic). Cats: soft tissue infections and dental infections due to S. aureus, S. intermedius, Streptococcus spp., C. perfringens and B. fragilis.

Dose regimen

2.5 mg/lb (wounds, abscesses, dental infections); 5.0 mg/lb (osteomyelitis) - dogs, Oral (liquid, 25 mg/mL), Every 12 hours, Maximum of 28 days. Cats: 5.0 to 10.0 mg/lb once every 24 hours for a maximum of 14 days.

Dogs: 2.5 mg /lb body weight every 12 hours for a maximum of 28 days for the treatment of canine infected wounds, abscesses and dental infections. 5.0 mg/lb body weight every 12 hours for a maxmum of 28 days fo r the treatment of osteomyelitis.

Extraction notes: Generic ANADA (Delmarva Laboratories). No studies: 'Based upon the formulation characteristics of the generic product, Delmarva Laboratories, Inc. was granted a waiver on May 16, 1997, from conducting an in vivo bioequivalence study for Clinsol®.' Pioneer Antirobe Liquid NADA 135-940; feline claims added without new data after the pioneer's exclusivity ended October 7, 1999. Quotes preserve PDF-extraction artifacts ('treatm ent', 'maxmum', 'fo r').

ClindaRobe™ NADA 200-383, Original approval, December 19, 2007; sponsor Teva Canada Ltd.; species: Dogs; foi_id 1134; FDA PDF

Indication

Skin infections (wounds and abscesses), deep wounds and abscesses, dental infections and osteomyelitis caused by susceptible strains of the designated microorganisms in dogs.

Dose regimen

2.5 to 15 mg per pound (infected wounds, abscesses, dental infections), Oral, every 12 hours, Maximum of 28 days; acute infections should not be treated more than three or four days without response. Osteomyelitis: 5.0 to 15 mg/lb every 12 hours for a minimum of 28 days (the osteomyelitis line is broken mid-word in the extracted text).

Recommended Dosage: Infected wounds, abscesses, and dental infections: 2.5 to 15 mg per pound of body weight every 12 hours for a maximum of 28 days.

Pharmacokinetics

Effectiveness

Blood-level bioequivalence study (in lieu of effectiveness): single-dose, two-period, two-sequence crossover of Novopharm CLINDAROBE 150 mg capsules vs Upjohn ANTIROBE 150 mg capsules in 18 healthy female beagle dogs, 7-day washout, blood sampled to 24 h (Study 980221, LAB Pre-Clinical Research International).; n = 18; primary endpoint: AUC and CMAX (log-transformed) with 90% confidence interval of generic minus pioneer within 80.00% - 125.00%; TMAX assessed clinically; result: Both AUC (99.6% - 122.7%) and CMAX (94.4% - 112.7%) fell within the bioequivalence bounds; TMAX difference judged clinically acceptable; bioequivalence achieved.

In the single-dose, two period, two sequence bioavailability study, 18 healthy female beagle dogs were random ized to two sequences in equal number.

Extraction notes: Original ANADA (2007). Approval rests on one blood-level bioequivalence study for the 150 mg strength plus in vitro dissolution data (85% dissolved within 15 minutes) supporting a biowaiver for the 25 mg and 75 mg capsules. The bioequivalence table was flattened by PDF extraction and the AUC value '22842.9.8' is printed that way in the source (units labelled μg*hr/mL although magnitudes suggest ng). The effectiveness quote reproduces the extraction artefact 'random ized'.

Clindamycin Hydrochloride Oral Liquid NADA 200-193, Supplemental approval, December 27, 2000; sponsor Cronus Pharma Specialities India Private Ltd.; species: Canine and feline (new); foi_id 993; FDA PDF

Indication

Supplement adds feline claims: therapy of wounds, abscesses and dental infections in cats (canine label: wounds, abscesses, dental infections and osteomyelitis).

Dose regimen

5.0 to 10.0 mg/lb body weight (11 to 22 mg/kg per day) - feline, Oral, Every 24 hours, Maximum of 14 days (cats). Canine label: 2.5 mg/lb every 12 hours for wounds, abscesses, dental infections; 5.0 mg/lb every 12 hours for osteomyelitis.

Feline: For therapy of wounds, abscesses, and dental infections, orally administer 5.0 to 10.0 mg/lb body weight every 24 hours for a maximum of 14 days (11 to 22 mg/kg body weight per day).

Extraction notes: Supplemental generic ANADA (Phoenix Scientific) adding feline claims after the pioneer's exclusivity ended October 7, 1999: 'No new data was required for the addition of the feline claims.' Bioequivalence to Antirobe Aquadrops (NADA 135-940) established by chemical equivalence (in vivo study waived December 8, 1995). Canine dose quote: 'infections, orally administer 2.5 mg/lb (1 mL/10lbs) body weight every 12 hours. For therapy of osteomyelitis orally administer 5.0 mg/lb (2 mL/10 lbs) body weight every 12 hours.'

Clintabs® NADA 200-316, Original approval, June 06, 2002; sponsor Virbac AH, Inc.; species: Canine; foi_id 1064; FDA PDF

Indication

Soft tissue infections (wounds and abscesses), dental infections and osteomyelitis caused by susceptible Staphylococcus aureus (aerobic) and by Bacteroides fragilis, B. melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens (anaerobic) in dogs.

Dose regimen

2.5 mg/lb (wounds, abscesses, dental infections); 5.0 mg/lb (osteomyelitis), Oral, every 12 hours, 28 day maximum for wounds/abscesses/dental infections; 28 day minimum for osteomyelitis.

For therapy of wounds, abscesses, and dental infections, orally administer 2.5 mg/lb body weight every 12 hours for a 28 day maximum. For therapy of osteomyelitis, orally administer 5.0 mg/lb body weight every 12 hours for a 28 day minimum.

Pharmacokinetics

Effectiveness

Bioequivalence study (in lieu of effectiveness): two-period, two-sequence, two-treatment crossover in 24 purebred Beagle dogs, single 150 mg Clintabs tablet vs single 150 mg Antirobe capsule after a 12 h fast, serum clindamycin by validated HPLC over 48 h (Covance Laboratories).; n = twenty-four (12 males, 12 females); primary endpoint: AUC 0-LOQ and Cmax of serum clindamycin (geometric means, ratio and confidence interval); result: Clintabs 150 mg tablets concluded bioequivalent to Antirobe 150 mg capsules (AUC ratio 1.07, Cmax ratio 1.0).

The investigation was conducted as a two periods, two sequences, and two-treatment crossover design employing twenty-four purebred Beagle dogs (12 males, 12 females).

Extraction notes: Original ANADA (2002) approved on a blood-level bioequivalence study only; no target animal safety or field effectiveness studies. Table 1 was flattened by PDF extraction; PK rows are quoted as extracted and the column order is described in 'conditions'. Species recorded as 'Canine' exactly as the summary states.

Clindamycin Hydrochloride Capsules NADA 200-298, Original approval, June 14, 2002; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 1047; FDA PDF

Indication

Antibiotic for the treatment of soft tissue infections, dental infections, and osteomyelitis in dogs.

Dose regimen

2.5 mg/lb (wounds, abscesses, dental infections); 5.0 mg/lb (osteomyelitis), Oral (capsules, 25/75/150 mg), Every 12 hours, Maximum of 28 days (wounds/abscesses/dental); minimum of 28 days (osteomyelitis)

Wounds, abscesses, and dental infections: 2.5 milligrams per pound of body weight every 12 hours for a ma ximum of 28 days. Osteomyelitis: 5.0 milligrams per pound of body weight every 12 hours for a minimum of 28 days.

Extraction notes: Generic ANADA (Phoenix Scientific). No studies: 'Based upon the formulation characteristics of the generic product, Phoenix Scientific Inc. was granted a waiver on June 30, 1998, from conducting an in vivo bioequivalence study for Clindam ycin Hydrochloride Capsules.' Pioneer Antirobe Capsules NADA 120-161. Quotes preserve PDF-extraction artifacts ('inf ections', 'ma ximum').

Clindamycin Hydrochloride Tablets NADA 200-813, Original approval, June 27, 2025; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs; foi_id 17171; FDA PDF

Indication

Skin infections (wounds and abscesses), deep wounds and abscesses, dental infections and osteomyelitis due to susceptible strains of the designated staphylococci and anaerobes in dogs.

Dose regimen

2.5-15.0 mg/lb (infected wounds, abscesses, dental infections), Oral, every 12 hours, Up to a maximum of 28 days if clinical judgement indicates; acute infections not continued beyond three or four days without response. Osteomyelitis: 5.0-15.0 mg/lb every 12 hours for a minimum of 28 days.

Dogs: Infected Wounds, Abscesses, and Dental Infections Oral: 2.5-15.0 mg/lb body weight every 12 hours Duration: Treatment with Clindamycin Hydrochloride Tablets may be continued up to a maximum of 28 days if clinical judgement indicates.

Pharmacokinetics

Effectiveness

Pivotal blood-level bioequivalence study (in lieu of effectiveness): randomized, masked, two-period, two-sequence, two-treatment single-dose crossover of generic 150 mg clindamycin tablet vs Antirobe 150 mg capsule in 30 fasted male dogs with 7-day washout (Study CLNC-KC2-5822, GLP); mixed-effect model on log CMAX and AUC.; n = 30; primary endpoint: CMAX and AUC (time 0 to last quantifiable sample) with 90% CI of geometric mean ratio within 0.80 - 1.25; result: Bioequivalence demonstrated on complete-case analysis (50 of 60 profiles; 10 dosing failures) after a significant sequence effect in the AUC model; generic tablet and RLNAD capsule concluded bioequivalent.

The study was conducted as a randomized, masked, two-period, two-sequence, two- treatment, single-dose crossover design using 30 dogs with a 7-day washout.

Extraction notes: Original ANADA (2025) for a tablet dosage form approved via suitability petition FDA-2021-P-0086; no target animal safety or clinical effectiveness studies. Adverse reactions: 'There were no serious adverse events reported during the study.' Biowaiver granted for 25 mg and 75 mg tablets on rapid dissolution (>85% in 15 minutes). Table II.1 was flattened by PDF extraction; rows quoted as extracted with column order in 'conditions'. Effectiveness quote reproduces the source line break artefact 'two- treatment'.

Clindamycin Hydrochloride Oral Drops NADA 200-398, Original approval, March 19, 2007; sponsor First Priority, Inc.; species: Dogs and cats; foi_id 1143; FDA PDF

Indication

Dogs: skin infections (wounds and abscesses), deep wounds and abscesses, dental infections and osteomyelitis due to susceptible designated organisms; cats: skin infections, deep wounds and infections, and dental infections due to susceptible designated organisms.

Dose regimen

Dogs: 2.5 to 15.0 mg/lb (1-6 mL/10 lbs) for wounds, abscesses and dental infections; 5.0 to 15.0 mg/lb (2-6 mL/10 lbs) for osteomyelitis, Oral, every 12 hours (dogs), Cats: 1-3 mL/5 lbs once every 24 hours for wounds, abscesses and dental infections depending on severity. 25 mg/mL solution.

Dogs: For therapy of wounds, abscesses, and dental infections, orally administer 2.5 to 15.0 mg/lb (1-6 mL/10 lbs) body weight every 12 hours. For therapy of osteomyelitis orally administer 5.0 to 15.0 mg/lb (2-6 mL/10 lbs) body weight every 12 hours.

Extraction notes: Original ANADA (2007) generic to Antirobe Aquadrops (NADA 135-940). No studies: the sponsor was granted a waiver from the in vivo bioequivalence requirement based on formulation characteristics (oral solution with the same active ingredient and concentration). Species recorded as 'Dogs and cats' exactly as stated; a dog application whose summary also covers cats. Indication quote copies the source spelling 'Staphyloccus'.

Antirobe® Capsules NADA 120-161, Supplemental approval, May 13, 2002; sponsor Zoetis Inc.; species: dogs; foi_id 380; FDA PDF

Indication

Treatment of infections in dogs caused by susceptible strains: skin infections (wounds and abscesses) due to coagulase positive staphylococci; deep wounds and abscesses, dental infections and osteomyelitis due to S. aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.

Dose regimen

2.5-15 mg/lb (skin infections, deep wounds/abscesses, dental infections); 5-15 mg/lb (osteomyelitis), Oral (capsules), Every 12 hours, Maximum of 28 days for skin/wound/dental infections; minimum of 28 days for osteomyelitis

The supplement provides for the use of clindamycin hydrochloride (ANTIROBE Capsules) in dogs at a dose range of 2.5-15 mg/lb body weight every 12 hours for skin infections (wounds and abscesses), deep wounds and abscesses, and dental infections. It also provides for a dose range in dogs of 5-15 mg/lb every 12 hours for osteomyelitis.

Extraction notes: Supplemental NADA (Pharmacia & Upjohn) adding a dose range (previously point doses), a 300 mg capsule and recent MIC data; Category II change, no exclusivity. No new studies: effectiveness and target animal safety sections refer to the June 6, 1984 and November 16, 1989 FOI summaries; 'a review of this data supports the upper end of the two dose ranges of 2.5-15 mg/lb and 5-15 mg/lb body weight every 12 hours for up to a maximum of 28 days in dogs.'

Antirobe Aquadrops® NADA 135-940, Supplemental approval, May 13, 2002; sponsor Zoetis Inc.; species: dogs and cats; foi_id 411; FDA PDF

Indication

Dogs: skin infections (wounds and abscesses) due to coagulase positive staphylococci; deep wounds and abscesses, dental infections and osteomyelitis due to S. aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens. Cats: skin infections, deep wounds/abscesses and dental infections due to the same organisms.

Dose regimen

Dogs: 2.5-15 mg/lb (skin infections, deep wounds/abscesses, dental); 5-15 mg/lb (osteomyelitis). Cats: 5-15 mg/lb, Oral (liquid, 25 mg/mL), Every 12 hours (dogs); every 24 hours (cats), Dogs: maximum 28 days (skin/wound/dental), minimum 28 days (osteomyelitis); cats: maximum 14 days

The supplement provides for the use of clindamycin hydrochloride (ANTIROBE AQUADROPS Liquid) in dogs at a dose range of 2.5-15 mg/lb body weight every 12 hours for skin infections (wounds and abscesses), deep wounds and abscesses, and dental infections. It also provides for a dose range in dogs of 5-15 mg/lb every 12 hours for osteomyelitis. In addition, this supplement provides for an expanded dose range of 5-15 mg/lb every 24 hours in cats.

Extraction notes: Supplemental NADA (Pharmacia & Upjohn) adding a dog dose range, expanding the cat dose range and adding MIC data; Category II change, no exclusivity. No new studies: effectiveness and safety sections refer to the earlier FOI summaries for ANTIROBE Capsules (NADA 120-161; 1984, 1989) and ANTIROBE AQUADROPS (1985, 1996), stating that a review of those data supports the lower and upper ends of the new dose ranges.

Antirobe Aquadrops® NADA 135-940, Supplemental approval, November 16, 1989; sponsor Zoetis Inc.; species: Dogs and cats (indication section lists both); foi_id 1703; FDA PDF

Indication

Dogs: skin infections (wounds and abscesses) due to coagulase-positive staphylococci; deep wounds and abscesses, dental infections and osteomyelitis due to susceptible Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, Clostridium perfringens and S. aureus. Supplement adds the dental infection (S. aureus) and anaerobic (deep wounds/abscesses, dental, osteomyelitis) claims.

Extraction notes: Very short reformatted (Section 508) 1989 supplemental summary: general information only, no dosage, no studies. Effect of supplement: 'This supplemental application provides for the following additional claims: Aerobic bacteria: for the treatment of dental infections caused by susceptible strains of Staphylococcus aure us.' plus anaerobic claims (soft tissue infections, dental infections, osteomyelitis due to Bacteroides fragilis, Bacteroides melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens). The indication quote preserves the summary's typo 'Fusobacterium ecrophorum'. The indication section also lists cat claims although the feline approval came in 1996.

Antirobe Aquadrops® NADA 135-940, Supplemental approval, October 07, 1996; sponsor Zoetis Inc.; species: Cats; foi_id 412; FDA PDF

Indication

Cats: treatment of soft tissue infections (wounds and abscesses) and dental infections caused by susceptible Staphylococcus aureus, Staphylococcus intermedius and Streptococcus spp. (aerobic) and of soft tissue infections (deep wounds and abscesses) and dental infections caused by susceptible Bacteroides fragilis and Clostridium perfringens (anaerobic).

Dose regimen

5.0 to 10.0 mg/lb body weight, Oral, Once every 24 hours, Depending on severity; up to a maximum of 14 days if clinical judgment indicates; stop after three to four days if no clinical response

ANTIROBE AQUADROPS Liquid is to be orally administered to cats at the dosage range of 5.0 to 10.0 mg/lb body weight once every 24 hours depending on the severity of the condition. Duration: Treatment with ANTIROBE AQUADROPS Liquid may be continued up to a maximum of 14 days if clinical judgment indicates.

Pharmacokinetics

Target-animal safety

dose multiples 1X, 3X, 5X; duration 42 days once daily (0, 11, 33, 55 mg/kg/day); 8 cats (control and 5X) kept a further 27-28 days for reversibility; animals 40.

The objective was to characterize the pharmacotoxic effects of a formulation containing clindamycin hydrochloride following oral administration once daily for 42 days (3X the maximum proposed clinical treatment of 14 days) in domestic shorthair cats at 1X, 3X, and 5X the minimum recommended daily therapeutic dose (11 mg/kg/day [5 mg/lb/day]). Following the dosing period, two animals per sex per group in both the control and high-dose groups were maintained on study without drug to assess reversibility of drug effects for an additional 27/28 days (females/males). A statistical evaluation of the results was not performed. This study was conducted in compliance with all applicable GLP regulations. ii. Test Animals: Forty (40) barrier reared domestic shorthair cats weighing 2.4 kg (5.3 lb) to 4.9 kg (10.8 lb) were distributed among the treatment groups as follows:

Effectiveness

Pivotal multilocation dose confirmation clinical field study (11 US small-animal practices) in privately owned cats with naturally occurring infected wounds and abscesses; 110 cats enrolled; randomized to clindamycin hydrochloride liquid 5.0 mg/lb orally once daily or amoxicillin trihydrate 5.0 mg/lb once daily for at least 7 consecutive days; evaluators masked; 20-day maximum treatment/observation period.; n = 57 (clindamycin) and 53 (amoxicillin) cats evaluated; primary endpoint: Overall therapeutic response (cure vs failure) evaluated 8 days post-treatment from daily lesion size, granulation/scab formation, exudate and rectal temperature; result: Cured 89.5% (51/57) clindamycin vs 83.0% (44/53) amoxicillin; clindamycin numerically superior, difference not statistically significant (p=0.19); non-inferiority decision criterion met; no relapses in 20 days.

"Cured" (Excellent or Good evaluation) 89.5 (51/57) 83.0 (44/53) "Not Cured" (Fair or Poor evaluation) 10.5 (6/57) 17.0 (9/53)

Adverse reactions

Extraction notes: This 1996 supplement to a dog NADA is a CAT summary (feline indications); the 'n_dogs' field holds cat counts. PK Table 4.10 was flattened; the row order is Cmax (μg/mL), tmax (hours), AUC0-LOQ (printed unit μg/h/hr), t1/2 (hours), capsules first then aqueous solution; no significant differences between formulations. Pivotal dose determination study (41 cats, induced wounds/abscesses): 5.0 and 10.0 mg/lb once daily for 10 days effective vs placebo and 2.5 mg/lb (day-6 culture score LS means 16.49, 13.07, 6.79, 7.93). UK dental study: 16/16 (100%) excellent/good with clindamycin 2.5 mg/lb BID for 5-10 days plus dental treatment vs 10/12 (83%) dental treatment only. Target animal safety: 15-day 10X (110 mg/kg/day) tolerance study in 20 cats and the 42-day 1X/3X/5X study in 40 cats (12/8/8/12 per group; table flattened); highest 24-h serum concentration 0.57 mcg/mL on day 14 at 55 mg/kg/day. Three-year exclusivity for the feline claims.