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ANDA Sponsors In Drivers Seat For Competitive Generic Therapy Exclusivity

 
• By Derrick Gingery

Draft guidance says US FDA will not assume a product has launched, the final requirement to receive the promised 180-day exclusivity, unless notified by the sponsor.

Generics

The US FDA will assume a designated competitive generic therapy product has not launched unless told otherwise, placing the burden on sponsors to trigger the incentive's 180-day marketing exclusivity as soon as they are able.

New draft guidance released Feb

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