PAR RECEIVES APPROVAL FOR GENERIC INDERAL LA

Par Pharmaceutical announced it has received final approval from the FDA for its abbreviated new drug application for generic propranolol hydrochloride extended-release (ER) in 60-, 80-, 120- and 160-mg capsules.

Par's drug 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 U.S. sales of Inderal LA are approximately $215 million, according to Par.

Par's generic propranolol ER is the product of a strategic partnership established in 2002 with Nortec Development Associates, an innovator in the development of controlled-release process technologies. Under terms of the agreement, Par will market, sell and distribute the product in the U.S. and retain the majority of profits realized from its sale. The drug will be manufactured collaboratively by Glatt and Par.

Glatt's CPS Technology is proprietary drug delivery technology that can be used in the development and manufacture of controlled-release drug products.

"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," Eric M. Mittleberg, Par's executive vice president for R&D, said.