FDAnews Drug Daily Bulletin

Actavis Gets Complete Response Letter for Transdermal Contraceptive Patch

Jan. 2, 2014

Actavis’ NDA for a progestin-only transdermal contraceptive patch has been turned down by the FDA, according to the company. The rejection comes about 10 months after the NDA was filed.

In a complete response letter, the FDA expressed concerns about differences in formulation between the norethindrone transdermal delivery system tested in a year-long, multicenter, open-label U.S. clinical trial and the patch the drugmaker intended to market.

At the time the agency accepted Actavis’ NDA for the drug, the company envisioned a product that would provide continuous delivery of norethindrone during a once-weekly dosing regimen.

Requests to the company for comment were not returned by press time Tuesday. Actavis says it is working closely with the FDA to address those concerns. — Lena Freund