NORTHVALE, N.J. — Elite Pharmaceuticals Inc. has received clearance to market phentermine HCl 37.5 mg tablets, an appetite suppressant.
Elite said Friday that it obtained Food and Drug Administration approval of the abbreviated new drug application for the generic medication under the name of Epic Pharma LLC, from which it had acquired the ANDA, and that transfer of the ANDA to Elite’s name will begin immediately.
Phentermine HCl tablets are the generic equivalent of the Adipex-P 37.5 mg tablets. The product and its equivalents had annual sales of approximately $40 million in 2010, according to Elite, which added that there are currently six other approved generic manufacturers.
Elite noted that its phentermine medication was part of a license agreement and a manufacturing and supply agreement with Precision Dose Inc., whose TAGI Pharma Inc. subsidiary will distribute the product. TAGI Pharma will market and sell the product, and Elite will manufacture it.
Phentermine is indicated for reducing weight in obese patients, to be used short-term and combined with exercise, diet and behavioral modification. The weight control drug works by helping to release certain chemicals in the brain that control appetite.
