Mylan Inc. is set to begin shipping nisoldipine extended-release tablets, indicated for the treatment of high blood pressure.


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Mylan OK'd for first-to-file generic Sular tablets

January 28th, 2011

PITTSBURGH – Mylan Inc. is set to begin shipping nisoldipine extended-release tablets, indicated for the treatment of high blood pressure.

The company said Friday that its Mylan Pharmaceuticals Inc. subsidiary received final approval from the Food and Drug Administration for nisoldipine extended-release (ER) tablets in strengths of 8.5 mg, 17 mg, 25.5 mg and 34 mg.

Mylan reported that it was the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification for nisoldipine ER Tablets and has been awarded 180 days of marketing exclusivity for all dosages.

Nisoldipine ER tablets are the generic version of Shionogi Pharma's Sular tablets, a hypertension medication, according to Mylan.

Nisoldipine ER tablets had U.S. sales of about $103 million for the 12 months ended Sept. 30, 2010, according to IMS Health data cited by Mylan.

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