OTC First Aid Antibiotic Monograph amendment
Revises the standards for bacitracin zinc-polymyxin B sulfate topical aerosol products to contain "in each gram, 120 units of bacitracin zinc and 2,350 units of polymyxin B," Oct. 4 Federal Register notice states. Monograph had provided for the product to contain "in each 90-gram container, 10,000 units of bacitracin and 200,000 units of polymyxin B." In response to a petition, FDA revised the monograph to give the concentration of antibiotics contained in each gram, rather than stating the concentration of antibiotics in each container.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.