Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate: what the FDA reviewed for dog products

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment NADA 200-553, Original approval, July 30, 2015; sponsor Domes Pharma S.A.; species: Dogs and cats; foi_id 1236; FDA PDF

Indication

Treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats due to organisms susceptible to one or more of the antibiotics in the ointment

Dose regimen

a small quantity of ointment (each gram: polymyxin B sulfate 10,000 units, bacitracin zinc 400 units, neomycin sulfate 5 mg), Ophthalmic (conjunctival sac beneath the lower eyelid), three or four times daily, cleanse area first; hold eyelids shut briefly after application

Each gram of ointment contains: polymyxin B sulfate 10,000 units, bacitracin zinc 400 units, and neomycin sulfate 5 mg (equivalent to 3.5 mg neomycin base). H. How Supplied 3.5 g tube I. Dispensing Status Rx J. Dosage Regimen Properly cleanse area to be treated. Foreign bodies, crusted exudates and debris should be carefully removed. Express a small quantity of ointment into the conjunctival sac beneath the lower eyelid three or four times daily.

Effectiveness

Generic (ANADA) approval; bioequivalence waived based on formulation characteristics (topical ophthalmic ointment with the same active ingredients, concentration and dosage form as RLNAD NEOSPORIN, NADA 065-485); no effectiveness or TAS studies required; result: Bioequivalence waiver granted

Based on the formulation characteristics of the generic product, Akorn Animal Health Inc was granted a waiver from the requirement to demonstrate bioequivalence for the generic product Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP.

Extraction notes: ANADA with bioequivalence waiver; no studies. Species/Class is 'Dogs and cats' (this summary is not dog-only). 'effectiveness' records the biowaiver statement. Dose quote spans General Information items G-J to ground the unit strengths.