Clindamycin: what the FDA reviewed for dog products

ClindaMed™ Oral Drops NADA 200-538, Original approval, April 19, 2013; sponsor Bimeda Animal Health Ltd.; species: Dogs and cats; foi_id 1226; FDA PDF

Indication

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

Dose regimen

2.5-15.0 mg/lb body weight (dogs: infected wounds, abscesses, dental infections), Oral, Every 12 hours, Up to a maximum of 28 days if clinical judgment indicates; stop after three or four days if no response. Osteomyelitis (dogs): 5.0-15.0 mg/lb every 12 hours for a minimum of 28 days. Cats: 5.0-15.0 mg/lb once every 24 hours, max 14 days.

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

Extraction notes: Generic ANADA (Cross Vetpharm Group Ltd./Bimeda). 'CVM did not require effectiveness studies for this approval.' and 'CVM did not require target animal safety studies for this approval.' Bioequivalence waived: 'Based on the formulation characteristics of the generic product, Cross Vetpharm Group Ltd. was granted a waiver from the requirement to demonstrate in vivo bioequivalence study for the generic product CLINDAMED (clindamycin) Oral Drops.' RLNAD ANTIROBE AQUADROPS NADA 135-940. Osteomyelitis dose quote: 'Dogs: Osteomyelitis Oral: 5.0-15.0 mg/lb body weight every 12 hours.'