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Agile's Twirla Suffers Scathing Critique By US FDA Ahead Of Advisory Cmte.

 
• By Michael Cipriano

Agile's transdermal contraceptive will go before the Bone, Reproductive and Urologic Drugs Advisory Committee as it nears the end of its third review cycle, although the agency appears ready to issue another complete response letter before it even hears from the panel.

FDA Advisory Committee Feature image

Is strike 3 on the way for Agile Therapeutics Inc.'s contraceptive transdermal system Twirla (levonorgestrel and ethinyl estradiol)?

The product will likely need to be saved by the US Food and Drug Administration's Bone, Reproductive and Urologic Drugs Advisory Committee for Agile to have any shot at approval, as the agency has virtually

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