logo
Plus   Neg
Share
Email

Actavis Says FDA Accepts NDA For Progestin-only Contraceptive Patch

Specialty pharmaceutical company Actavis, Inc. (ACT) Monday said the U.S. Food and Drug Administration has accepted for filing its New Drug Application for a progestin-only transdermal contraceptive patch, Norethindrone Transdermal Delivery System, for use by women to prevent pregnancy.

The acceptance of the NDA for filing means FDA has determined that the application is sufficiently complete to permit a substantive review. Under the Prescription Drug User Fee Act, the FDA's goal under standard review is to review and act on the NDA by December 27.

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

Actavis said that once-weekly dosing with the patch may improve compliance and convenience in progestin-only contraceptive users, as well as provide more consistent average plasma norethindrone levels than oral progestin-only products.

The NDA includes data from a 12-month, multicenter, open-label clinical trial conducted in the U.S. Actavis submitted the NDA to the FDA on February 26.

The stock is down 2.5 percent in pre-market activity at $117.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
In a move likely to further inflame global trade tensions, President Donald Trump has threatened to impose a 20 percent tariff on all cars imported to the U.S. from the European Union. Trump claimed he would impose the new tariffs unless the EU removes tariffs and trade barriers placed on the U.S. The Federal Reserve has determined that the largest U.S. banks are strongly capitalized and would be able to lend to banks as well as households during a severe global economic recession. This is the fourth straight year that all banks have met the Federal Reserve's standards. The first round of results of the supervisory stress tests were released by the central bank on Thursday. The "safety" driver behind the wheel of a self-driving Uber was streaming a television show on her smartphone up until about the time of a fatal crash in March, according to a report from the Tempe Police Department. Uber's self-driving Volvo SUV, which was traveling at under 44 miles per hour, had struck and killed a pedestrian in Arizona on March 18.
Follow RTT