Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals
Inc. has received final approval from the FDA for its Abbreviated New Drug
Application (ANDA) for Nisoldipine Extended-release (ER) 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
sales of approximately $103 million for the 12 months ending Sept. 30, 2010,
according to IMS Health.