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Press Release

Lannett Receives Approval For Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg And 40 mg

Lannett Company,Inc.
Posted on: 05 Sep 17

PR Newswire

PHILADELPHIA, Sept. 5, 2017

PHILADELPHIA, Sept. 5, 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 Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, the therapeutic equivalent to the reference listed drug, Nexium Delayed-Release Capsules, 20 mg and 40 mg, a.k.a. "the purple pill," of AstraZeneca Pharmaceuticals LP. For the 12 months ended July 2017, total U.S. sales of Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, at Average Wholesale Price (AWP) were approximately $1.4 billion, according to IMS.

"The approval for Esomeprazole Magnesium Delayed-Release Capsules demonstrates our ability to develop high quality, complex formulations," said Arthur Bedrosian, chief executive officer of Lannett. "This approval, our seventh thus far in 2017, comes from our wholly owned subsidiary, Kremers Urban Pharmaceuticals. I commend our regulatory, R&D, legal, production, supply chain and staff for this approval of a Paragraph IV product. Our sales team will now begin to utilize their skills, as they always do, to gain market share. A number of competitors are currently marketing the product; we anticipate launching ours in the next several 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

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 Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, and the planned launch of recently approved 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.


Robert Jaffe

Robert Jaffe Co., LLC

(424) 288-4098


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SOURCE Lannett Company, Inc.

PR Newswire

Last updated on: 05/09/2017

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