FDA approves Lannett's ANDA for Phentermine Resin Extended-Release Capsules

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Lannett Company, Inc. (NYSE AMEX: LCI) today announced the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for Phentermine Resin Extended-Release Capsules, 15 mg and 30 mg, representing the fourth product approval the company has received in the last five weeks. Phentermine Resin Extended-Release Capsules, 15 mg and 30 mg, are therapeutically equivalent to the reference listed drug, Ionamin® Capsules, 15 mg and 30 mg, of UCB, Inc. This product will be sold through bariatric clinics.

“This product is a first-time generic, this will help Americans combat obesity and its effect on our healthcare system.”

"Recognizing the struggle that many have with losing weight, we are pleased to offer Phentermine Resin Extended-Release Capsules, 15 mg and 30 mg base, which further rounds out our portfolio of anti-obesity treatments," said Arthur P. Bedrosian, president and chief executive officer of Lannett. "This product is a first-time generic, this will help Americans combat obesity and its effect on our healthcare system."

Bedrosian went on to say that the company has 14 ANDAs currently pending at the FDA and he is optimistic that a number of them will be approved in the coming months.

Lannett's wholly owned pain management subsidiary, Cody Laboratories, will produce the Active Pharmaceutical Ingredient (API) for this product.

Phentermine Resin is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction.

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