Lannett Announces Approval For Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL (0.5 mg/mL)

PHILADELPHIA, May 16, 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 Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL (0.5 mg/mL), the therapeutic equivalent to the reference listed drug, Xyzal® Oral Solution, 2.5 mg/5 mL (0.5 mg/mL), of UCB Inc.  

Lannett Logo (PRNewsFoto/Lannett Company, Inc.)

"The approval of Levocetirizine Dihydrochloride Oral Solution expands our line of oral generic drugs," said Arthur Bedrosian, chief executive officer of Lannett.  "Our Levocetirizine Dihydrochloride Oral Solution will be manufactured in Carmel, New York by our wholly owned subsidiary, Silarx Pharmaceuticals."

Levocetirizine Dihydrochloride Oral Solution is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

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 Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL (0.5 mg/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.

Contact:

Robert Jaffe


Robert Jaffe Co., LLC


(424) 288-4098

 

SOURCE Lannett Company, Inc.


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