Lannett Announces Approval For Lopinavir And Ritonavir Oral Solution USP, 80 Mg/20 Mg Per mL

--Company May Be Eligible for 180 Days of Generic Drug Marketing Exclusivity--

PHILADELPHIA, Jan. 3, 2017 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval last week from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Lopinavir and Ritonavir Oral Solution USP, 80 mg/20 mg per mL, the therapeutic equivalent to the reference listed drug, Kaletra® Oral Solution of AbbVie Inc.  Lannett, the first applicant to file a substantially complete ANDA for Lopinavir and Ritonavir Oral Solution USP, 80 mg/20 mg per mL with a Paragraph IV certification, may be eligible for 180 days of generic drug marketing exclusivity for the product, although FDA has not made a final determination at this time. 

"Lopinavir and Ritonavir Oral Solution, indicated for HIV-1 infections, represents the twelfth product approval we received in calendar 2016 and extends our line of oral generic drugs," said Arthur Bedrosian, chief executive officer of Lannett.  "This approval comes from our wholly owned subsidiary, Silarx Pharmaceuticals, which we acquired nearly 18 months ago to diversify our manufacturing capabilities and differentiate our product offering.  I commend our entire regulatory team for the approval of this first-to-file, Paragraph IV product.  We anticipate launching our product shortly."

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 Lopinavir and Ritonavir Oral Solution USP, 80 mg/20 mg per mL and expectations regarding 180 days of generic drug marketing exclusivity, 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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