Healthcare Industry News:  Merck 

Biopharmaceuticals Generics FDA

 News Release - March 29, 2016

Lannett Receives FDA Approvals For Two Products

Company Expects to Launch Temolozomide Capsules Shortly

PHILADELPHIA, March 29, 2016 -- (Healthcare Sales & Marketing Network) -- Lannett Company, Inc. (LCI) today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Potassium Chloride Extended-release Capsules USP, 8 mEq and 10 mEq, the therapeutic equivalent to the reference listed drug of Actavis Labs FL, Inc., and Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, the therapeutic equivalent to the reference listed drug Temodar® Capsules of Merck & Co. According to IMS, total U.S. sales in 2015 of Potassium Chloride Extended-release Capsules USP, 8 mEq and 10 mEq and Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg at Average Wholesale Price (AWP) were approximately $89 million and $206 million, respectively.

"The Potassium Chloride product represents the second approval received from our acquisition of Kremers Urban (KU)," said Arthur Bedrosian, chief executive officer of Lannett. "This is our second approval for Temozolomide, a product for which our KU subsidiary also recently received FDA approval and the only drug candidate in the pipelines of both Lannett and KU. We expect to launch Temozolomide within the next few months and are evaluating launch options for our Potassium Chloride product."

About Lannett Company, Inc.

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical 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 statement, including, but not limited to, successfully commercializing Potassium Chloride Extended-release Capsules USP, 8 mEq and 10 mEq and Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, whether expressed or implied, are subject to market and other conditions, and 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 risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. 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.


Source: Lannett Company

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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