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:2/12/2016)... , Feb. 12, 2016  SI-BONE, Inc., a medical device company ... ("iFuse"), a minimally invasive surgical (MIS) device indicated for fusion for ... Services, Inc. (NGS), the Medicare Administrative Contractor (MAC) covering the states ... Maine , Massachusetts , ... New York , Rhode Island , ...
(Date:2/12/2016)... and SEOUL, South Korea ... Menarini and Macrogen, Inc. today announced they will ... innovative procedures for precision medicine in cancer. The ... Biosystems, DEPArray™ digital-sorting technology with Macrogen,s high-throughput Next ... certified under the Clinical Laboratory Improvement Amendments (CLIA) ...
(Date:2/12/2016)... , Feb. 12, 2016  Apellis ... completed a $47.1 million Series D preferred ... Asset Management, Hillhouse Capital Group and venBio ... Venture Investments, AJU IB Investment, and Epidarex ... used to further advance clinical trials in ...
Breaking Medicine Technology:
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... Miami Dental ... implants to their Miami dental office. Beginning in January, Miami Dental Specialists will ... Miami Dental Specialists are the first office to be chosen by the dental implant ...
(Date:2/12/2016)... ... February 12, 2016 , ... Atlantic Information Services, ... Plans and PBMs,” an upcoming Feb. 24 webinar that will discuss ways health ... therapeutic categories, such as the $1,000-per-pill hepatitis C treatment Sovaldi and high-cost PCSK9 ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... The Central Coast Autism Spectrum Center (CCASC) ... is to provide a night of fun for teens with and without special needs to ... welcomed and included at the event. The dance will take place on Saturday, Feb. 13 ...
(Date:2/12/2016)... CA (PRWEB) , ... February 12, 2016 , ... With the exception of restorative dentistry, ... of dental decay. With the recent approval by the FDA, there is a now ... similar to fluoride varnish, SDF is very simple and quick to apply. The application ...
(Date:2/11/2016)... ... February 11, 2016 , ... SPH Analytics ... action analytics leader’s population health solutions, MDinsight® and IndiGO®, for its primary care ... healthcare system. Details of the contract were not disclosed. , As the healthcare ...
Breaking Medicine News(10 mins):