Mylan Inc. 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.
The details can be read here.
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