FDA gives tentative approval to Impax’s generic Vytorin

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday gave tentative approval to Impax Laboratories’ gneneric Vytorin (ezetimibe and simvastatin) tablets. The drug, available in 10-mg/10-, 20-, 40- and 80-mg dosage strengths is indicated to treat high cholesterol. 

 

“We are pleased to receive tentative approval from the FDA for our generic version of Vytorin tablets," Impax CEO and president Fred Wilkinson said. “We will continue to work with the FDA to gain final approval upon the expiration of the U.S. patents and associated pediatric exclusivity on April 25, 2017, and are currently planning to be among the first generic products to market”

 

The drug had annual sales of approximately $714 million for the 12 months ending December 2015.