Healthcare Industry News: U.S. Food and Drug Administration
News Release - June 1, 2018
Lannett Receives FDA Approval For Levofloxacin Oral Solution; Imminent Launch AnticipatedPHILADELPHIA, June 1, 2018 -- (Healthcare Sales & Marketing Network) -- 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 Levofloxacin Oral Solution USP, 25 mg/mL, the therapeutic equivalent to the reference listed drug, LevaquinŽ Oral Solution, 25 mg/mL, of Janssen Pharmaceuticals, Inc. For the 12 months ended April 2018, total U.S. sales of Levofloxacin Oral Solution USP, 25 mg/mL, was approximately $6 million, according to IMS.
"Our ANDA for Levofloxacin Oral Solution, a paragraph IV product, was approved three weeks ahead of the Target Action Date," said Tim Crew, chief executive officer of Lannett. "While the commercial opportunity for our Levofloxacin product is modest, the expected near-term launch is further evidence of our growing operational effectiveness. We continue to make progress unlocking the value of our many approved products pending launch and expect to announce additional product launches in the coming months."
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 Levofloxacin Oral Solution USP, 25 mg/mL, and the planned launches of other 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.
Source: Lannett Company
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