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Classified in: Health
Subject: FDA

Lannett Receives Approval For Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg And 10 mg/300 mg



PHILADELPHIA, June 22, 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 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg, the therapeutic equivalent to the reference standard drug, Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg, of Mikart, Inc. The product is also marketed under the brand names Vicodin®, Vicodin ES® and Vicodin HP®. For the 12 months ended April 2017, total U.S. sales of Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg, at Average Wholesale Price (AWP) were approximately $67.1million, according to IMS.

Lannett Logo (PRNewsFoto/Lannett Company, Inc.)

"The approval for Hydrocodone Bitartrate and Acetaminophen Tablets is an important and valuable combination drug product for our pain management franchise," said Arthur Bedrosian, chief executive officer of Lannett.  "This approval, combined with two other recently approved ANDAs, will benefit our fiscal 2018 revenues.  With 20 drug applications pending at the FDA we believe additional approvals are forthcoming."

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 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 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.

Contact:  

Robert Jaffe


Robert Jaffe Co., LLC


(424) 288-4098

 

SOURCE Lannett Company, Inc.


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News published on 22 june 2017 at 06:53 and distributed by: