Navigation Links
Actavis' NDA for Progestin-Only Patch Accepted for Filing by FDA
Date:5/13/2013

PARSIPPANY, N.J., May 13, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) 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.  The acceptance for filing does not provide any assurance that the FDA will ultimately approve the NDA.  Under the Prescription Drug User Fee Act (PDUFA), the FDA's goal under standard review is to review and act on the NDA by December 27, 2013.Actavis' progestin-only patch is designed to provide continuous delivery of norethindrone to the systemic circulation during a once-weekly, seven-day dosing regimen.  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., in accordance with FDA guidance for a contraceptive study.  Actavis submitted the NDA to the FDA on February 26, 2013.

About ActavisActavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.  The Company has global and U.S. headquarters in Parsippany, New Jersey, USA. 

Operating as Actavis Pharma, the Company develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries.  Actavis Specialty Brands is the Company's global branded specialty pharmaceutical business focused in the Urology and Women's Health therapeutic categories.  Actavis Specialty Brands also has a portfolio of 5 biosimilar products in development in Women's Health and Oncology.

For press release and other company information, visit Actavis' Web site at http://www.actavis.com.

Forward-Looking Statement Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Actavis' products, ; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and  Actavis' Annual Report on Form 10-K for the year ended December 31, 2012.  Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.CONTACTS: Investors:Lisa DeFrancesco (862) 261-7152Media:Charlie Mayr(862) 261-8030(Logo: http://photos.prnewswire.com/prnh/20130124/NY47381LOGO )

 


'/>"/>
SOURCE Actavis, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Actavis Cancels Presentation at Bank of America Merrill Lynch Healthcare Conference
2. Actavis Confirms Early Stage Discussions Regarding Potential Combination with Warner Chilcott plc
3. Actavis, Inc. to Present at the Bank of America Merrill Lynch 2013 Health Care Conference
4. Actavis First Quarter 2013 Net Revenue Increases 24% to $1.9 Billion
5. Actavis Acquires Worldwide Rights for Valeants Metronidazole 1.3% Vaginal Gel
6. Actavis, Inc. to Host First Quarter 2013 Earnings Conference Call and Webcast
7. Former Clinton Deputy Solicitor General sheds light on flaws in Federal Trade Commissions case in FTC v. Actavis Inc.
8. Actavis, Inc. to Present at the Barclays 2013 Global Healthcare Conference
9. Actavis, Inc. to Present at the Cowen & Company 33rd Annual Health Care Conference
10. Actavis Full Year 2012 Net Revenue Increases 29% to $5.91 Billion
11. Actavis, Inc. to Present at the RBC Capital Markets Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... Oct. 4, 2017  According to the Centers for Disease Control and ... October . PhysicianOne Urgent Care is helping communities across Massachusetts ... , by offering no-cost* flu shots through the end of the ... certain health insurance regulations. ... time to get a flu shot is by the end of October, ...
(Date:10/2/2017)... 2, 2017 Halo Labs announces the European launch of ... the HORIZON at MIBio 2017 in Cambridge, U.K ... particulate matter in biopharmaceutical samples with unprecedented speed and sensitivity while ... technique Backgrounded Membrane Imaging. ... HORIZON subvisible particle analysis system ...
(Date:9/27/2017)... , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading ... announced that its MyDario product is expected to appear on The Dr. ... The Dr. Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. Oz Show ... The segment ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... The International Association of Eating Disorders ... for the field of eating disorders, announces the opening of early registration for ... Florida at the Omni Resort at ChampionsGate. , The annual iaedp™ ...
(Date:10/13/2017)... ... 2017 , ... Many families have long-term insurance that covers care for a ... waiver for care if the client has a cognitive impairment diagnosis. , “What ... is often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... will be giving viewers the lowdown on sciatica in a new episode of ... that focuses on current events and innovation and investigates each subject in-depth with ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... are now treating sleep apnea using cutting-edge Oventus O2Vent technology. As ... serious sleep disorder characterized by frequent cessation in breathing. Oral appliances can offer ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):