FDA Approves Par’s Generic Inderal

Par said Monday the U.S. Food and Drug Administration approved its generic version of Wyeth’s Inderal LA.

Inderal, which generates annual U.S. sales of $215 million, is indicated for treating hypertension angina pectoris due to coronary atherosclerosis, migraine and hypertrophic subaortic stenosis.

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, Par’s executive vice president of pharmaceutical research and development.

Par, which developed its product in collaboration with Glatt and Nortec, will market, sell and distribute the drug in the United States and retain the majority of profits.