Actavis Receives Final Approval for Generic Version of Exalgo
DUBLIN, May 13, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Mallinckrodt Inc.'s Exalgo (Hydromorphone Hydrochloride Extended-release Tablets 8 mg, 12 mg and 16 mg). Actavis intends to begin shipping its product shortly and believes that, under applicable Hatch Waxman rules, it may be entitled to marketing exclusivity.
Exalgo is indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. For the 12 months ending February 28, 2014, Exalgo® had total U.S. sales of approximately $230 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.
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 impact of competitive products and pricing; FDA interpretation of applicable laws and regulations affecting Actavis' entitlement to a period of generic drug marketing exclusivity; 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; risks associated with potential claims that Actavis' products infringe third party patents or other intellectual property rights; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; 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 period ended December 31, 2013, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.
Exalgo® is a registered trademark of Mallinckrodt LLC.
SOURCE Actavis plc
Posted: May 2014