FDA Seeks More Details On Actavis' NDA For Progestin-only Contraceptive Patch

(RTTNews) - Specialty pharmaceutical company Actavis Plc (ACT) Tuesday confirmed that its subsidiary has received a complete response letter from the U.S. Food and Drug Administration for its New Drug Application for a progestin-only transdermal contraceptive patch, Norethindrone Transdermal Delivery System, for use by women to prevent pregnancy.

Actavis had submitted the NDA to the FDA on February 26, 2013.

According to the company, the items raised in the complete response letter mainly related to questions regarding difference between the transdermal patch used in the clinical trial and the to-be-marketed transdermal patch, which represents a different size/formulation.

The 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 U.S., in accordance with FDA guidance for a contraceptive study.

Actavis said it intends to work closely with the FDA to address the items raised in the complete response letter.

Actavis' progestin-only patch is designed to provide continuous delivery of norethindrone to the systemic circulation during a once-weekly, seven-day dosing regimen.

On May 13, Actavis had announced that FDA accepted for filing its NDA for the progestin-only transdermal contraceptive patch. Under the Prescription Drug User Fee Act, the FDA's goal under standard review was to review and act on the NDA by December 27.

ACT closed Monday's regular trading at $165.96 on the NYSE.