Agile Therapeutics,Inc. (NASDAQ:AGRX) Files An 8-K Other EventsItem 8.01.Other Events.
On July27, 2017, Agile Therapeutics,Inc. (“Agile”) announced that it had received a letter from the U.S. Food and Drug Administration (“FDA”) acknowledging that the resubmission of the the New Drug Application (“NDA”) for its lead product candidate, Twirla®, an investigational low-dose combined hormonal contraceptive patch (AG200-15), was a complete response to a February2013 Complete Response Letter (“CRL”) from the FDA. The FDA established December26, 2017 as the target Prescription Drug User Fee Act (“PDUFA”) goal date.
A copy of Agile’s press release is attached hereto as Exhibit99.1 and is hereby incorporated by reference herein.
Item 8.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit Number
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Description
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99.1
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Press release issued by Agile Therapeutics,Inc. dated July27, 2017.
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AGILE THERAPEUTICS INC ExhibitEX-99.1 2 a17-18496_2ex99d1.htm EX-99.1 Exhibit 99.1 Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla® FDA Assigns Prescription Drug User Fee Act (PDUFA) Goal Date of December 26,…To view the full exhibit click here
About Agile Therapeutics,Inc. (NASDAQ:AGRX)
Agile Therapeutics, Inc. is a women’s health specialty pharmaceutical company. The Company is focused in the development and commercialization of prescription contraceptive products. The Company has developed a transdermal patch technology, called Skinfusion. The Company’s lead product candidate is Twirla, also known as AG200-15, is a combined hormonal contraceptive (CHC) patch. In addition to Twirla, the Company is developing a pipeline of other new transdermal contraceptive products, including AG200-ER, which is a regimen designed to allow a woman to extend the length of her cycle; AG200-SP, which is a regimen designed to provide a shortened hormone-free interval, and AG890, which is a progestin-only contraceptive patch intended for use by women who are unable or unwilling to take estrogen. Each of its product candidates utilizes its Skinfusion technology designed to deliver contraceptive-levels of hormones to the blood stream through the skin over a seven-day period.