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Apotex' Aleve PM Rival Could Have 180-Day Exclusivity As A CGT

Executive Summary

US consumers currently don't have access to enough private label/store brand competition for Aleve PM (naproxen/diphenhydramine), the FDA decides in granting Apotex its first OTC ANDA approval with Competitive Generic Therapy designation and eligibility for a type of exclusivity unlike any other previously allowed for OTCs.

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