Mylan Inc receives FDA approval for Nisoldipine extended-release tablets

Tue. July 29, 2008; Posted: 08:46 AM

Jul 29, 2008 (M2 EQUITYBITES via COMTEX) -- SCRX | Quote | Chart | News | PowerRating -- Mylan Inc (NYSE: MYL), a generic and specialty pharmaceutical company, said on 28 July that its subsidiary, Mylan Pharmaceuticals Inc, has announced the receipt of 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. The latter reported annual US sales of approximately USD94m for the 12 months ending 31 March 2008 for the three respective strengths. Nisoldipine ER is the first generic version of Sular ER to be introduced in the United States. The product will be shipped with immediate effect.

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For full details on Mylan Inc (MYL) click here. Mylan Inc (MYL) has Short Term PowerRatings of 4. Details on Mylan Inc (MYL) Short Term PowerRatings is available at This Link.

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