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pharmiweb.com today | 27 April 2017

Impax Announces FDA Approval and Launch of a Generic Version of Vytorin® (Ezetimibe/Simvastatin Tablets)

Impax Laboratories, Inc., a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug Administration (FDA) approval for a generic version of Vytorin® (ezetimibe/simvastatin tablets), 10/10, 10/20, 10/40 and 10/80 mg, and immediately initiated commercialization activities of this first-to-market opportunity. 

"We are pleased to be one of the first companies to offer a generic version of Vytorin® and provide patients with an affordable treatment option," said Paul Bisaro, President and Chief Executive Officer of Impax.  "This launch demonstrates our ability to develop, manufacture and bring to market new opportunities that enhance our generic portfolio." ...

Ezetimibe/simvastatin tablets had annual brand sales of approximately $678 million in the United States, according to IMS Health (NSP) for 12 months ending February 2017. 

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