PITTSBURGH, July 28 Mylan Inc. (NYSE: MYL) todayannounced that its subsidiary, Mylan Pharmaceuticals Inc., has received finalapproval from the U.S. Food and Drug Administration (FDA) for its AbbreviatedNew Drug Application (ANDA) for Nisoldipine Extended-release (ER) Tablets, 20mg, 30 mg and 40 mg.
Nisoldipine ER Tablets, indicated for the treatment of hypertension, arethe generic version of Sciele Pharma's Sular(R) ER Tablets, which had annualU.S. sales of approximately $94 million for the 12 months ending March 31,2008, for these three strengths. Mylan's Nisoldipine ER, which is beingshipped immediately, is the first generic version of Sular ER to be introducedin the United States.
Currently, Mylan has 93 ANDAs pending FDA approval, 21 of which arepotential first-to-file opportunities.
Mylan Inc., with a presence in more than 90 countries, ranks among theleading diversified generic and specialty pharmaceutical companies in theworld. The company maintains one of the industry's broadest - and highestquality - product portfolios, supported by a robust product pipeline; owns acontrolling interest in the world's second largest active pharmaceuticalingredient manufacturer; and operates a specialty business focused onrespiratory and allergy therapies.
SOURCE Mylan Inc.