Mylan Launches Generic Hypertension Drug
Mylan Pharmaceuticals has received final FDA approval for generic versions of Sciele Pharma’s anti-hypertensive Sular extended release (ER) in 20-, 30- and 40-mg strengths.
Mylan’s nisoldipine ER is the first generic version of Sular ER (nisoldipine) to be launched in the U.S., the firm said. The ’741 patent protecting the brand drug expired June 8, according to the Orange Book.
In January, the FDA approved formulations of Sular in 8.5-, 17-, 25.5- and 34-mg strengths. The new Sular formulation uses SkyePharma’s Geomatrix technology, which is designed to provide a lower dose of the drug for each of its previously marketed doses. The brand drug had annual U.S. sales of approximately $94 million for the 12 months ending March 31, according to Mylan.
Mylan has 93 ANDAs pending FDA approval, 21 of which are potential first-to-file opportunities, according to the company.