Lannett Receives FDA Approval For Oxycodone And Acetaminophen Tablets USP, 5 mg/325 mg And 10 mg/325 mg
Published: Sep 27, 2017
PHILADELPHIA, Sept. 27, 2017 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg and 10 mg/325 mg, the therapeutic equivalent to the reference listed drug, Percocet® Tablets, 5 mg/325 mg and 10 mg/325 mg, of Vintage Pharmaceuticals, LLC. For the 12 months ended July 2017, total U.S. sales of Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg and 10 mg/325 mg, at Average Wholesale Price (AWP) were approximately $571 million, according to IMS.
"To say that we are on a roll is putting it mildly," said Arthur Bedrosian, chief executive officer of Lannett. "Oxycodone and Acetaminophen Tablets extends our pain management franchise and represents our ninth approval thus far in calendar 2017, which is quite an accomplishment for Lannett. We are hopeful that we can exceed the 11 product approvals received last year; I commend our entire team for their diligence and ongoing efforts. We expect to commence marketing the drug along with other approved products in the next several months. Our planned product launches, combined with our on-going integration and cost reduction efforts, are just some of the factors that give us confidence Lannett's future is bright."
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 Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg and 10 mg/325 mg, and the planned launch of recently approved products, 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.
Robert Jaffe Co., LLC
SOURCE Lannett Company, Inc.