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FDA Prioritizes ANDAs Ready For Launch After 180-Day Exclusivity Expires

 
• By Sue Sutter

In effort to speed competition and lower drug prices, US regulator will prioritize review of generic drug applications likely to be ready for approval on or shortly after the expiration of first-filer's exclusivity; experts say the move appears to formalize what once had been an informal Office of Generic Drugs policy.

priority button

With the US FDA's announcement that it will prioritize review of abbreviated new drug applications (ANDAs) ready for approval once a first generic's marketing exclusivity expires, the agency appears to be formalizing an informal generic review division policy, with the aim of speeding competition and lowering drug prices.

On Nov

Priority Review Policy Expansion

"Submissions for drug products blocked by 180-day exclusivity that have been tentatively approved or submissions for drug products blocked by 180-day exclusivity that OGD determines will likely be ready for approval upon or shortly after expiration of the

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