Healthcare Industry News:  migraine 

Biopharmaceuticals Generics FDA

 News Release - August 13, 2007

Actavis Receives Approval for Generic Inderal LA Capsules in the U.S.

REYKJAVIK, Iceland, Aug. 13, 2007 (Healthcare Sales & Marketing Network) -- Actavis Group, the international generic pharmaceuticals company, today 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 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.

Doug Boothe, Executive VP of U.S. 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.

About Actavis

Actavis is one of the world's leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. With headquarters in Iceland, Actavis has operations in 39 countries, with 11,000 employees. Actavis expects 2007 sales to total EUR1.6bn, with approximately one-third of these sales coming from the United States, the company's single largest market. In the US alone, the company made 38 ANDA filings in 2006 and expects to file 40-45 in the year 2007 along with 18-20 new product launches. The company's U.S. operations are located in New Jersey, Maryland, North Carolina and Florida.

More information about Actavis in the United States can be found at http://www.actavis.us.


Source: Actavis

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