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news.Lannett, a company that develops, manufactures, packages, markets and distributes generic pharmaceutical products for a range of indications, has been granted approval for its abbreviated new drug application (ANDA) for Phentermine Hydrochloride Blue/White Seed capsules USP, 30mg, by FDA.
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The drug is the generic equivalent of Sandoz’s reference listed drug (RLD) Phentermine Hydrochloride capsules USP, 30mg.
Phentermine Hydrochloride, an appetite suppressant of the amphetamine and phenethylamine class, is indicated as a short-term adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater that or equal to 30kg/m2, or 27kg/m2 in the presence of other risk factors
Arthur Bedrosian, president and CEO of Lannett, said: “Phentermine Hydrochloride Blue/White Seed Capsules USP, 30mg, is an important new addition to the company’s offering of obesity management products. The company intends to launch this new product in the current first quarter of fiscal 2011.”