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news.Par Pharmaceutical has received final approval from the FDA for its abbreviated new drug application for propranolol hydrochloride extended release capsules.
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Propranolol hydrochloride (HCl) extended release (ER) is the generic equivalent of Wyeth Pharmaceuticals’ Inderal LA and is used to treat hypertension, angina pectoris due to coronary atherosclerosis, migraine and hypertrophic subaortic stenosis. Annual US sales of Inderal LA are approximately $215 million, said Par.
Par’s propranolol ER is the product of a partnership established in 2002 with Nortec Development Associates. Under terms of the agreement, Par will market, sell and distribute the product in the US and retain the majority of profits from its sale. Propranolol HCl ER will be manufactured collaboratively by Par and Glatt Pharmaceutical Services.
“This propranolol HCl ER capsule is an example of a very difficult-to-develop, therapeutically equivalent product, now being made available to patients for the first time as a generic product,” said Eric Mittleberg, executive vice president of pharmaceutical R&D at Par.