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Watson Hopes Accelerated Approval For Progesterone Gel Remains Option

 
• By Sue Sutter

Company will meet with FDA to determine a path forward now that the agency has issued a “complete response” letter for progesterone vaginal gel 8% for reducing the risk of preterm birth in women with a short cervix, Watson CEO Bisaro says.

Allergan PLC intends to discuss with FDA whether the accelerated approval pathway could provide a regulatory lifeline for progesterone vaginal gel 8% for reducing the risk of preterm birth now that the agency, as expected, has issued a “complete response” letter.

During a Feb. 27 analyst conference presentation, Watson President and CEO Paul Bisaro said the company intends to meet with FDA to determine if there is a viable path toward...

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