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Latest Aleve PM Copy Could Have 180-Day Exclusivity From More Competition

 
• By Malcolm Spicer

US consumers currently don't have access to enough private label/store brand competition for Aleve PM (naproxen/diphenhydramine), 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.

Apotex exterior

Apotex Inc. is the first OTC drug firm to take a swing at landing a type of exclusivity the US Food and Drug Administration is granting to encourage development of more generic competition to brand name products.

US consumers currently don't have access to adequate private label and store brand competition for Aleve PM (naproxen sodium 220...

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More from Policy & Regulation

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

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• By Malcolm Spicer

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• By Malcolm Spicer

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