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news.Mylan Laboratories has received final approval from the FDA for its abbreviated new drug application for propranolol hydrochloride extended-release capsules.
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The tablets have been approved in different strengths, including 60mg, 80mg, 120mg and 160mg.
Propranolol hydrochloride extended-release (ER) capsules are the generic version of Wyeth Pharmaceutical’s Inderal LA, which had US sales of approximately $201 million for the same strengths for the 12-month period ended December 31, 2006, according to IMS Health.
Inderal is a beta-blocker that affects the heart and circulation and is used to treat hypertension and heart conditions. Mylan said the product will be shipped immediately.