Mylan Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for propranolol hydrochloride extended-release (ER) capsules in 60mg, 80mg, 120mg and 160mg strengths. Propranolol hydrochloride ER capsules are the generic version of Wyeth’s beta blocker, Inderal LA, which had US sales of approximately $201 million for the same strengths for the 12-month period ended Dec. 31, 2006, according to IMS Health.
The FDA has granted priority review status to Gilead Science’s hypertension drug ambrisentan on a priority basis. Ambrisentan is a potential treatment for pulmonary arterial hypertension, a type of high blood pressure that affects the lungs and leads to heart failure. Priority FDA review typically takes six months, only half as long as the one year a drug is typically under review.