Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla PRINCETON, N.J., May 17, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced it has resubmitted to the U.S. Food and Drug Administration (FDA) the NDA for its lead product candidate, Twirla®, an investigational low-dose combined hormonal contraceptive patch (AG200-15). Agile resubmitted the NDA in response to a December 2017 Complete Response Letter (CRL) from the FDA, which identified deficiencies relating to (i) quality control adhesion test methods for the Twirla manufacturing process, (ii) observations identified during an inspection of a facility of our third-party manufacturer for the Twirla NDA that must be resolved, and (iii) questions on the in vivo adhesion properties of Twirla and their potential relationship to the SECURE clinical trial results. The resubmitted NDA includes the results from a com
On Feb. 1, 1961, twins Debbie and Donna Horst arrived at the White House to fanfare. The 6-year-olds, decked out in fancy dresses and satin sashes, found themselves surrounded by a pressing crowd and a sea of blinding flashbulbs as they made their way to see Jacqueline Kennedy. The girls -- both born with holes in their aortas -- were meeting with the first lady to kick off a national campaign to raise awareness about congenital heart defects. "There were hundreds of reporters because this was Jacqueline Kennedy' first public act as first lady," Debbie said. She recalls being startled when the reporters asked Mrs. Kennedy if they could move in closer. "It was frightening because they all jumped at us at once." The Pennsylvania twins, just a few weeks from turning 7, were among the first "Heart Fund Sweethearts" in the campaign to raise money as well as awareness. The month before, they'd met up with Micki and Patricia Gane, also of Pennsylvania