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Amneal Pharmaceuticals LLC

www.amneal.com

Latest From Amneal Pharmaceuticals LLC

Amneal’s Amicar Rival Gets CGT Exclusivity

After receiving a CGT designation by the FDA for its generic version of Amicar, Amneal gets 180 days of exclusivity.

Generic Drugs Regulation

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

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.

United States Regulation

Patience Pays Off For Kyowa Kirin As Nourianz Finally Gets US FDA OK

The Japanese firm's original 2007 NDA was rejected in 2008 but it kept faith in the drug, now approved as an adjunct to levodopa/carbidopa. At least one competitor is waiting in the wings.

Approvals Neurology

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

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.
OTC Drugs Drug Approval Standards
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