Lannett Receives FDA Approval For Temozolomide Capsules
PHILADELPHIA, Feb. 11, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that its wholly owned subsidiary, Kremers Urban Pharmaceuticals Inc. (KU), has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for 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 Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg at Average Wholesale Price (AWP) were approximately $206 million.
"Temozolomide is an important chemotherapy agent used to treat a certain type of brain tumor," said Arthur Bedrosian, chief executive officer of Lannett. "This product represents the first approval received from our recently completed acquisition of KU. We expect to commence marketing shortly."
About Lannett Company, Inc.:
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 Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, whether expressed or implied, is 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.
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SOURCE Lannett Company, Inc.