Lannett Receives FDA Approval For Diazepam Oral Solution, 5 mg/5 mL

PHILADELPHIA, June 28, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Diazepam Oral Solution, 5 mg/5 mL, the therapeutic equivalent to the reference listed drug, Diazepam Oral Solution, 5 mg/5 mL, of Roxane Laboratories, Inc. According to IMS, total U.S. sales in 2015 of Diazepam Oral Solution, 5 mg/5 mL, at Average Wholesale Price (AWP) were approximately $4 million.

“We believe our Diazepam Oral Solution product will be the second on the market,” said Arthur Bedrosian, chief executive officer of Lannett. “We expect to commence marketing the product in our fiscal 2017 first quarter, adding to a number of expected product launches in our coming fiscal year, which begins July 1, 2016.”

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 Diazepam Oral Solution, 5 mg/5 mL, 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.