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.
“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. About Lannett Company, Inc.: Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications. For more information, visit the company’s website at www.lannett.com. This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statements, including, but not limited to, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the successful commercialization of Phentermine Resin Extended-Release Capsules equivalent to 15 mg and 30 mg base, the difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully commercialize products upon approval, Lannett’s estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company’s Form 10-K and other documents filed with the Securities and Exchange Commission from time to time. These forward-looking statements represent the company's judgment as of the date of this news release. The company disclaims any intent or obligation to update these forward-looking statements.
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