NDA for Progestin-Only Patch Accepted for Filing by FDA
Actavis announced that the FDA has accepted its New Drug Applications (NDA) for filing for a progestin-only transdermal contraceptive patch (norethindrone transdermal delivery system) to prevent pregnancy in women.
The progestin-only patch is designed to continuously deliver norethindrone systemically during a once-weekly, seven-day dosing regimen. Once-weekly dosing may improve compliance and convenience in progestin-only contraceptive users. It may also provide more consistent average plasma norethindrone levels than oral progestin-only products.
On February 26, 2013, Actavis submitted the NDA to the FDA based on data from a 12-month, multicenter, open-label clinical trial.For more information call (800) 432-8534 or visit www.actavis.com.