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Agile Therapeutics wins FDA review extension of NDA for Twirla contraceptive

The PDUFA (Prescription Drug User Fee Act) goal date has been extended from November 16 to February 16, 2020

Agile Therapeutics - Agile Therapeutics Inc announces the US Food and Drug Administration has extended the goal date for its review of the New Drug Application for its investigational prescription contraceptive patch Twirla
Twirla is a low-dose prescription contraceptive delivered through the skin via the company’s proprietary patch

Agile Therapeutics Inc (NASADQ:AGRX) announced Thursday the US Food and Drug Administration has extended the goal date for its review of the New Drug Application (NDA) for Twirla, an investigational prescription contraceptive patch.

The PDUFA (Prescription Drug User Fee Act) goal date has been extended from November 16 to February 16, 2020, according to a statement.

On October 30, the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met to discuss the benefits and risks of Twirla and voted 14 to 1, with one abstention, that the benefits of Twirla (AG200-15) in the prevention of pregnancy outweigh the risks to support approval. 

READ: Agile Therapeutics stock rockets after Twirla contraceptive patch gets strong backing from FDA advisory committee

Although the FDA considers the non-binding recommendation of this panel, the final decision regarding the approval of the product is made by the FDA alone.

After the BRUDAC meeting, at the FDA’s request, Agile submitted additional information to the NDA concerning topics discussed at the BRUDAC meeting. FDA determined that these submissions constitute a major amendment and will take additional time to review.

According to FDA’s current PDUFA Performance Goals, an FDA decision to extend the review period typically is limited to situations where review of the new information could address an outstanding issue(s) and potentially lead to approval in the current review cycle.

“We look forward to continuing our discussions with the FDA,” said CEO Al Altomari. “We remain committed to bringing this important contraceptive option to women.” 

Contact the author: [email protected]

Follow him on Twitter @PatrickMGraham

 

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NASDAQ:AGRX
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Agile Therapeutics Inc (NASDAQ:AGRX) CEO Al Altomari tells Proactive Investors the FDA has accepted for review its new drug application resubmission for Twirla, its low-dose combined hormonal contraceptive patch. Altomari says this was a big day for the company, and looks forward to the...

on 05/31/2019

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