FDAnews
www.fdanews.com/articles/89113-fda-approves-mylan-s-generic-inderal-la

FDA APPROVES MYLAN'S GENERIC INDERAL LA

February 19, 2007

Mylan Laboratories announced that Mylan Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application for generic propranolol hydrochloride extended-release capsules, 60, 80, 120 and 160 mg.

The drug is the generic version of Wyeth Pharmaceutical's Inderal LA, which had U.S. sales of approximately $201 million for the same dosage strengths in 2006, according to IMS Health.

Inderal is a synthetic beta-adrenergic receptor-blocking agent indicated for the management of hypertension, the management of angina pectoris, the prophylaxis of migraines and for the management of hypertrophic subaortic stenosis.

Mylan said it would begin shipping its product immediately.