Healthcare Industry News: rosuvastatin
News Release - May 2, 2016
Allergan Receives FDA Approval and Launches First Generic Version of CRESTOR(R) (rosuvastatin)DUBLIN, May 2, 2016 -- (Healthcare Sales & Marketing Network) -- Allergan plc (AGN), a leading global pharmaceutical company, today confirmed that it has received final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for rosuvastatin calcium 5, 10, 20 and 40 mg tablets, the generic version of AstraZeneca's CRESTOR® (rosuvastatin) tablets. Following receipt of the FDA approval, Allergan is the first company to launch a generic version of CRESTOR® to customers in the U.S.
"This first-to-market launch demonstrates the talent of our Generics team in developing, manufacturing and bringing to market high-quality, affordable versions of widely used medications like CRESTOR®. This is expected to be the largest generic launch in 2016, benefiting patients and reducing cost for U.S. health systems," said Robert Stewart, Allergan's Executive Vice President & President, Generics and Global Operations.
Under the terms of the agreement reached with AstraZeneca on March 25, 2013, Allergan has launched its generic version of CRESTOR® 67 days prior to July 8, 2016, the expiration of pediatric exclusivity.
For the 12 months ended March 31, 2016, CRESTOR® had total U.S. brand sales of approximately $6.5 billion, according to IMS Health data.
CRESTOR® is a licensed trademark of AstraZeneca.
Allergan plc (AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model—Growth Pharma. Allergan is focused on developing, manufacturing, and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines, and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, health care providers, and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan's website at www.allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's 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 Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
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