Mylan Inc. announced that its subsidiary, Mylan Pharmaceuticals Inc, has received final approval from the US 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 ER tablets, which had annual US 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, a company press release said.

Currently, Mylan has 93 ANDAs pending FDA approval, 21 of which are potential first-to-file opportunities.