FDA approves Actavis' generic Inderal
REYKJAVIK, Iceland Actavis Group this month announced that it has received approval from the Food and Drug Administration to market propranolol hydrochloride extended-release capsules. Distribution of the product will commence immediately.
Propranolol hydrochloride extended-release capsules are the generic equivalent of Wyeth Pharmaceuticals’ Inderal LA capsules and are available in 60 mg, 80 mg, 120 mg and 160 mg dosage 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.
"The launch of propranolol is an important milestone for Actavis," said Doug Boothe, executive vice president of U.S. Commercial and Administration. "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 United States were approximately $192 million for the 12 months ended June 2007, according to IMS health data.