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Competitive Generic Therapy Designations Growing Despite Lack Of Guidance

 
• By Derrick Gingery

US FDA developing document describing program operations, but that has not stopped sponsors from requesting and receiving the breakthrough-like designation. 

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BOSTON -- The US FDA's Office of Generic Drugs is designating ANDAs as competitive generic therapies, making them available for additional exclusivity upon approval, even though program operations and expectations remain largely a mystery for sponsors.

Maryll Toufanian, acting director of the OGD Office of Generic Drug Policy, told the Pink Sheet in a June 26 interview following a session at the Drug Information Association Annual Meeting that the lack of guidance on program function has not tempered the

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