PITTSBURGH, July 28 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nisoldipine Extended-release (ER) Tablets, 20 mg, 30 mg and 40 mg.
Nisoldipine ER Tablets, indicated for the treatment of hypertension, are the generic version of Sciele Pharma's Sular(R) ER Tablets, which had annual U.S. sales of approximately $94 million for the 12 months ending March 31, 2008, for these three strengths. Mylan's Nisoldipine ER, which is being shipped immediately, is the first generic version of Sular ER to be introduced in the United States.
Currently, Mylan has 93 ANDAs pending FDA approval, 21 of which are potential first-to-file opportunities.
Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.
|SOURCE Mylan Inc.|
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