Actavis receives FDA OK for generic Inderal capsules

Actavis Group has announced that it has received approval from the U.S. Food & Drug Administration to market Propranolol Hydrochloride extended-release capsules. Distribution of the product will commence immediately.

Propranolol Hydrochloride extended-release (ER) capsules are the generic equivalent of Wyeth Pharmaceuticals' Inderal(R) LA capsules and available in 60mg, 80mg, 120mg and 160 mg doasage strengths. Propranolol ER capsules are indicated for the treatment of high blood pressure, long-term management of angina pectoris and prophylaxis of common migraine headaches.

Doug Boothe, Executive VP of US Commercial & Administration said: "The launch of Propranolol is an important milestone for Actavis. With one of the strongest product pipelines in the industry, we continue to grow our business by increasing our product offering with affordable high quality generic drugs. This launch is also in line with our strategy to further grow our business in the controlled release product market and exemplifies our capability in controlled release oral solid products."

Annual brand sales of Propranolol ER capsules in the U.S. were approximately US$192 million for the twelve months ending June 2007 according to IMS health data.