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Twirla Gets Strong Advisory Cmte. Endorsement Even After US FDA Pans Application

 
• By Michael Cipriano

The Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-1, with one abstention, in favor of approving Agile's transdermal contraceptive patch Twirla in a sharp divergence from the US FDA's negative evaluation of the drug, though it remains an open question of how the agency will ultimately come down.

FDA Advisory Committee Feature image

In a surprising vote, US Food and Drug Administration's Bone, Reproductive and Urologic Drugs Advisory Committee overwhelmingly endorsed Agile Therapeutics Inc.'s transdermal contraceptive patch Twirla, a decision that could make the agency reevaluate – and possibly even alter – its rather dim view of the application. 

The near unanimous recommendation (14-1, with one abstention) seemed like an impossible mountain for Agile to climb going into the...

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