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Watson May Bypass Progesterone Gel 8% For Second-Generation Product

 
• By Sue Sutter

The extent of additional clinical work required pursuant to an FDA “complete response” letter will have to be balanced against the remaining patent life on the product, for which Watson was seeking an indication to prevent preterm birth in women with a short cervix.

Facing a short patent life and an FDA “complete response” letter for its progesterone vaginal gel 8%, Allergan PLC may choose to forego further clinical work toward a preterm birth prevention indication and instead focus on developing a second-generation pipeline product or abandon the category entirely.

In a move that came as little surprise, FDA issued a “complete response” letter requesting additional clinical data for Watson...

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