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:3/23/2017)... The key factors driving the growth of dialysis ... growth and increasing healthcare expenditure. Some of the noteworthy trends ... ESRD patients, rising demand for home PD treatment and huge ... market is hindered by high treatment costs and stringent regulations. ... Complete ...
(Date:3/23/2017)... -- Transportation Insight, a multi-modal lead logistics solutions provider receives ... with expertise serving clients in the food industry. Vice ... was named a 2017 Food Logistics Champion: ... publication exclusively dedicated to covering the movement of product ... has brought to Transportation Insight a wealth of knowledge ...
(Date:3/23/2017)... INDIANAPOLIS , March 23, 2017 /PRNewswire/ ... and the William Sansum Diabetes Center have established a ... affected by diabetes through enhanced research, education and care. ... cardiovascular disease bears a disproportionate weight on Latino families ... David Kerr , M.D., FRCPE, director of Innovation ...
Breaking Medicine Technology:
(Date:3/24/2017)... Antonio, TX (PRWEB) , ... March 24, 2017 , ... ... new clinic which can be found at 9618 Huebner Road. The clinic is the ... PT, OCS, Clinic Director, and Dr. Ali Higgins, PT, will provide care from the ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... wanted to create a communications platform that positions them as the go-to thought ... ONS reinvented their online publication as an always-on, always-fresh news, views and advocacy ...
(Date:3/24/2017)... ... 2017 , ... Gastro Health (“GH”) ( http://www.gastrohealth.com ) ... colonoscopy at the HyGIeaCare® Center that is to be located adjacent to the ... The HyGIeaCare® Prep, cleared by the U.S. Food and Drug Administration (FDA), will ...
(Date:3/24/2017)... ... March 24, 2017 , ... “Vintage and Harvest A ... minister and college Bible teacher residing in North Carolina with his wife, Anna Marie. ... blessed them with six grandchildren. David is also the author of “Shadow and Substance.” ...
(Date:3/23/2017)... Texas (PRWEB) , ... March 23, 2017 , ... The ... 3rd location in the greater Houston Area. The new location is located at 2255 ... Luke’s Hospital in Springwoods Village. This newest location will provide patients living in the ...
Breaking Medicine News(10 mins):