Mylan Receives Approval for First-to-File Generic Sular

Mylan Inc. 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 for Nisoldipine Extended-release Tablets, 8.5 mg, 17 mg, 25.5 mg and 34 mg. Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for Nisoldipine ER Tablets and has been awarded 180 days of marketing exclusivity. Nisoldipine ER Tablets are the generic version of Shionogi Pharma's Sular® Tablets, a treatment for hypertension. Nisoldipine ER Tablets had U.S. sales of approximately $103 million for the 12 months ending Sept. 30, 2010, according to IMS Health. Product from Mylan is available for shipment.