Lannett Receives Approval For Additional Dosage Strengths Of Hydrocodone Bitartrate And Acetaminophen Tablets USP

--New Dosage Strengths of 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg Represent Lion's Share of the Market and Complement Previously Approved Dosage Strengths--

PHILADELPHIA, June 26, 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/325 mg, 7.5 mg/325 mg and 10 mg/325 mg, the therapeutic equivalent to the reference listed drug, Norco® Tablets, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg, of Allergan Pharmaceuticals International Limited.  The product is also marketed under the brand name Lortab® 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg.  For the 12 months ended April 2017, total U.S. sales of Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg, at Average Wholesale Price (AWP) were approximately $744.3 million, according to IMS.

Lannett Logo (PRNewsFoto/Lannett Company, Inc.)

"The dosage strengths approved by this ANDA currently represent the lion's share of the market for Hydrocodone Bitartrate and Acetaminophen Tablets and complement our already approved strengths of 5 mg/300 mg, 7.5 mg/300 mg, and 10 mg/300 mg," said Arthur Bedrosian, chief executive officer of Lannett.  "New product approvals are the growth engine of generic drug manufacturers.  We have received four approvals this month and five since the beginning of calendar 2017.  These approvals expand our pain management franchise and increase the total number of products we offer to the marketplace.  We plan to launch all of our recently approved products in our new fiscal year, which begins next week.  With a number of drug applications pending at the FDA, both our own filings and those of our alliance partners, 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/325 mg, 7.5 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.

Contact:

Robert Jaffe


Robert Jaffe Co., LLC


(424) 288-4098

 

SOURCE Lannett Company, Inc.


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