Agile therapeutics announces favorable outcome of fda advisory committee meeting for its investigational transdermal contraceptive patch, twirla® (ag200-15)

Agile therapeutics, inc. announced a positive outcome from meeting of the bone, reproductive and urologic drugs advisory committee (brudac) of the u.s. food and drug administration (fda). the brudac met to discuss the company’s new drug application (nda) for its lead product candidate, twirla® (ag200-15), an investigational combined hormonal contraceptive patch. the brudac voted 14 to 1, with 1 abstention, that the benefits of twirla (ag200-15) in the prevention of pregnancy outweigh the risks to support approval. agile resubmitted the nda for twirla (ag200-15) on may 16, 2019. the advisory committee’s non-binding vote is taken into consideration by the fda as part of its evaluation of the nda. the fda has assigned a pdufa (prescription drug user fee act) goal date of november 16, 2019, for the completion of its review of the twirla (ag200-15) nda.
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