FDA accepts NDA for Agile's contraceptive patch
PRINCETON, N.J. — The Food and Drug Administration has accepted a new drug application for a low-dose, once-weekly contraceptive patch from Agile Therapeutics, the drug maker said.
Agile said it expects the FDA to respond to its NDA for AG200-15 — a combination hormonal contraceptive patch, which in clinical studies has been shown to deliver a low dose of ethinyl estradiol, as well as a dose of levonorgestrel that is consistent with that of low-dose oral contraceptives — by first quarter 2013. The patch is applied once weekly for three weeks, followed by a fourth patch-free week. The patch may be applied to the abdomen, buttocks or upper torso, is soft and flexible with a cloth-like, silky feel and designed to provide adhesion, comfort and appearance, Agile said.
"We are very pleased with the FDA's acceptance of our AG200-15 NDA filing," Agile president and CEO Al Altomari said. "This is an important milestone for our company and reflects the unwavering commitment of the entire Agile team to advance a new contraceptive option for women. We will work closely with the FDA to bring AG200-15 to market as soon as possible."