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Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced it has received final approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for propranolol hydrochloride (HCl) extended release (ER) capsules in 60-, 80-, 120- and 160 mg dosage strengths.
Propranolol HCl ER is the generic equivalent of Wyeth Pharmaceuticals’ Inderal(R)LA and is used to treat hypertension, angina pectoris due to coronary atherosclerosis, migraine and hypertrophic subaortic stenosis. Annual U.S. sales of Inderal(R) LA are approximately $215 million.
Par’s propranolol ER is the product of a strategic partnership established in 2002 with Nortec Development Associates, Inc., 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. Propranolol HCl ER will be manufactured collaboratively by Glatt and Par.
“Propranolol HCl ER makes use of Glatt’s CPS Technology(R), proprietary drug delivery technology that can be used in the development and manufacture of drug products with controlled release properties,” said Eric M. Mittleberg, Ph.D., executive vice president, Pharmaceutical Research and Development. “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.”
“This challenging product has been available for generic competition for many years, and this first successful generic development and launch was enabled by Glatt’s innovative drug delivery technologies and unsurpassed controlled release capabilities,” said Oliver W. Mueller, executive vice president, Glatt Pharmaceutical Services.
Dr. Mittleberg added: “This partnership has enabled Par to continue 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 a team effort combining the best skills of Nortec, Par and Glatt to bring to market a very challenging generic equivalent,” said Kenneth Olsen, founder, president and CEO of Nortec Development Associates, Inc. Nortec, founded in 1984 as a third-party contract R&D company, holds controlled-release patents and has licensed other controlled-release products to companies outside the U.S.
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