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Par Pharmaceutical Companies, Inc. (NYSE: PRX) announced today that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for propranolol hydrochloride (HCl) extended release (ER) capsules in 60 -, 80 -, 120 - and 160 mg dosages.

Propranolol HCl ER is the generic equivalent of Inderal Wyeth Pharmaceuticals (R) and LA is used to treat hypertension, angina pectoris due to coronary atherosclerosis, migraine and hypertrophic subaortic stenosis. Annual sales of U.S. Inderal (R) LA are approximately $ 215 million.

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For propranolol ER is the product of a strategic partnership established in 2002 with Nortec Development Associates, Inc., an innovator in technology development process controlled release. Under the terms of the agreement, Par will market, sell and distribute the product in the U.S. and retain the majority of profits from its sale. Propranolol HCl ER is being built by Glatt and.

"Propranolol HCl ER makes use of the CPS Glatt Technology (R) proprietary technology drug delivery that can be used in the development and manufacture of drugs with controlled release properties," said Eric Mittleberg, Ph.D. D., executive vice president, research and pharmaceutical development. "This propranolol HCl ER capsule is an example of very difficult to develop, produce therapeutically equivalent, currently available to patients for the first time as a generic product."

"This product has been difficult for generic competition available for many years, and this first successful generic development and launch was enabled by Glatt innovative drug delivery and controlled release unmatched capabilities," said Oliver W. Mueller, executive vice president, Glatt Pharmaceutical Services.

Dr. Mittleberg added: "This partnership enabled by continuing to better leverage its R & D resources, and we look forward to continuing this collaboration, allowing our complementary skills and expertise to be used to develop difficult generic products for the benefit of patients and health care providers. "

"This product is the result of teamwork involving the best skills of Nortec, PAR and Glatt to bring to market a generic version extremely difficult," said Kenneth Olsen, founder, president and CEO of Nortec Development Associates, Inc. Nortec, founded in 1984, a contract of third-party R & D company, holds patents for controlled release and has licensed other controlled release products to companies outside the U.S.

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