Mylan Wins Final Approval for Generic Hypertension Drug
July 29, 2008
Mylan has announced that its subsidiary, Mylan Pharmaceuticals, received final approval from the FDA for its abbreviated new drug application for nisoldipine extended-release tablets, 20mg, 30mg and 40mg.
Mylan’s nisoldipine extended-release (ER) tablets, indicated for the treatment of hypertension, are the generic version of Sciele Pharma’s Sular ER tablets.
Mylan’s Nisoldipine ER, which is being shipped immediately, is said to be the first generic version of Sular ER to be introduced in the US. Currently, Mylan has 93 abbreviated new drug applications pending FDA approval, 21 of which are potential first-to-file opportunities.