|By PR Newswire||
|February 28, 2014 08:00 AM EST||
DUBLIN, Feb. 28, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Dronedarone Hydrochloride Tablets 400 mg. Actavis' ANDA product is a generic version of Sanofi's Multaq®, which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF.
Sanofi and Sanofi-Aventis U.S. LLC filed suit against Actavis on February 26, 2014 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA until Jan. 1, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Multaq® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending December 31, 2013, Multaq® had total U.S. sales of approximately $319 million, according to IMS Health data.
Actavis plc (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in Dublin, Ireland and U.S. administrative headquarters in Parsippany, New Jersey, USA.
Actavis develops and manufactures generic, brand, branded generic, legacy brands and Over-the-Counter (OTC) pharmaceutical products and has commercial operations in approximately 60 countries. The Company's North American branded pharmaceuticals business is focused principally in the Women's Health, Urology, Gastroenterology and Dermatology therapeutic categories with a strong pipeline of products in various stages of development. Actavis also has a portfolio of five biosimilar products in development in Women's Health and Oncology. Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.
For press release and other company information, visit Actavis' Web site at http://www.actavis.com.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing information as of the date of this release. It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actual results may differ materially from Actavis' current expectations depending upon a number of factors, risks and uncertainties affecting Actavis' business. These factors include, among others; the difficulty of predicting the timing and outcome of the pending patent litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Actavis and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc's Annual Report on Form 10-K for the year ended December 31, 2013. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.
Multaq® is a registered trademark of Sanofi.
SOURCE Actavis plc
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