Mylan's generic Sular gets FDA OK
PITTSBURGH — The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.
Mylan announced the approval Friday of nisoldipine extended-release tablets in the 8.5-mg, 17-mg, 25.5-mg and 34-mg strengths. The drug is a generic version of Shionogi Pharma’s Sular, which had sales of about $103 million during the 12-month period ended in September 2010, according to IMS Health.
Mylan was the first company to file a regulatory approval application for the drug and is thus entitled to 180 days in which to compete directly with the branded version under the provisions of the Hatch-Waxman Act of 1984, the law that created a regulatory approval pathway for generic pharmaceutical drugs.