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Biopharmaceuticals Generics FDA

 News Release - December 23, 2019

Lannett Receives FDA Approvals For Two Dosage Strengths Of Butalbital, Acetaminophen And Caffeine Capsules

PHILADELPHIA, Dec. 23, 2019 -- (Healthcare Sales & Marketing Network) -- Lannett Company, Inc. (NYSE: LCI) today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Butalbital, Acetaminophen and Caffeine (BAC) Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg. The two dosage strengths of BAC Capsules, have a combined estimated IQVIA market value of approximately $68.6 million for the 12 months ending October 2019, although actual generic market values are expected to be lower.

"We have commenced marketing both dosage strengths of our newly approved BAC Capsules," said Tim Crew, chief executive officer of Lannett. "Thus far in fiscal 2020, we have launched about half a dozen products, among them are Posaconazole, Prednisone and Cyproheptadine, and we expect to launch as many as 12 products in the coming six months."

BAC Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg are the therapeutic equivalents of the reference listed drugs BAC Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg of Nexgen Pharma, Inc. and Mayne Pharma Inc., respectively.

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 Butalbital, Acetaminophen and Caffeine Capsules, USP, 50mg/300mg/40mg and Butalbital, Acetaminophen and Caffeine Capsules, USP, 50mg/325mg/40mg, and the expected launch of as many as 12 products in the second half of fiscal 2020, which includes several products in the next two months, 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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