Actavis' Generic Version of Micardis Receives FDA Approval
DUBLIN, Jan. 8, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis. Actavis intends to launch the product immediately.
As a "first applicant" to submit a substantially complete ANDA, Actavis is eligible for 180 days of generic market exclusivity.
Micardis is an angiotensin II receptor blocker indicated for the treatment of hypertension, to lower blood pressure and cardiovascular risk reduction in patients unable to take ACE inhibitors. For the 12 months ending September 30, 2013, Micardis® had total U.S. sales of approximately $274 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 Pharma markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. Actavis Specialty Brands is a global branded specialty pharmaceutical business focused principally in the Urology and Women's Health therapeutic categories, as well as Gastroenterology and Dermatology. Actavis Specialty Brands 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; 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; the difficulty of predicting how the FDA will interpret applicable Hatch Waxman rules related to Actavis' entitlement to marketing exclusivity and the possibility that an adverse interpretation of such rules could negatively affect Actavis' marketing exclusivity; 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 quarterly report on Form 10-Q for the quarter ended September, 2013. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.
Micardis® is a registered trademark of Boehringer Ingelheim.
SOURCE Actavis plc
Posted: January 2014