The US Food and Drug Administration (FDA) has issued a complete response letter to Actavis' subsidiary for its New Drug Application (NDA) for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy.

The company stated that it intends to work closely with the FDA to address the items raised in the complete response letter which primarily related to questions regarding the difference between the transdermal patch used in the clinical trial and the to-be-marketed transdermal patch, which represents a different size/formulation.

Data submitted to the FDA in support of approval of NDA for progestin-only patch included results from a 12-month, multicenter, open-label clinical trial conducted in the US, in accordance with FDA guidance for a contraceptive study. Actavis submitted the NDA to the FDA on February 26, 2013.

Actavis plc is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The company markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries, and operates a global branded specialty pharmaceutical business focused in the Women's Health, Urology, Gastroenterology and Dermatology therapeutic categories.