Lannett Company, Inc. announced that it received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, the therapeutic equivalent to the reference listed drug, Aggrenox® Capsules, 25 mg/200 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.
PHILADELPHIA, March 27, 2019 /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 Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, the therapeutic equivalent to the reference listed drug, Aggrenox® Capsules, 25 mg/200 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. Total U.S. sales of Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, was approximately $174.6 million for the 12 months ended January 2019, according to IQVIA, although actual generic market values are expected to be lower.
“The commercial opportunity for our Aspirin and Extended-Release Dipyridamole Capsules product, which was developed internally, is meaningful,” said Tim Crew, chief executive officer of Lannett. “The launch of this product is expected in the near term and is part of an ongoing and concerted effort to add new products to our offering. Since January of last year, we have commenced marketing nearly 20 products and we expect to maintain that launch pace moving forward. We continue to make substantial investments in product development and expand in-licensing opportunities to replenish our pipeline, which is sizable relative to our portfolio, and add revenues and improve profitability.”
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 Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, 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.
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SOURCE Lannett Company, Inc.
Company Codes: NYSE:LCI
