Lannett Receives Two FDA Approvals For Lansoprazole Delayed-Release Capsules USP, One Each For Full Prescription And OTC
Published: Oct 02, 2017
PHILADELPHIA, Oct. 2, 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 Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg, the therapeutic equivalent to the reference listed drug, Prevacid® Delayed-Release Capsules, 15 mg and 30 mg, of Takeda Pharmaceuticals. The company also announced that it received FDA approval of its ANDA for Lansoprazole Delayed-Release Capsules USP, 15 mg (OTC), the bioequivalent to the reference listed drug, Prevacid® 24HR Delayed-Release Capsules, 15 mg, of GlaxoSmithKline. For the 12 months ended July 2017, total U.S. sales at Average Wholesale Price (AWP) of Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg, was approximately $76 million, according to IMS.
"Each and every member of the Lannett team deserves credit for the successful stream of recent product approvals and the launches to come," said Arthur Bedrosian, chief executive officer of Lannett. "We are closing in on a record year for product approvals, with 11 received thus far in calendar 2017. The last five product approvals we received were not included in our financial guidance calculation for fiscal 2018 and therefore the launch of these products represents upside to the outlook we provided at the end of August. We expect to commence marketing our prescription Lansoprazole Delayed-Release Capsules product in the next several months.
"The two approvals for Lansoprazole were received by our wholly owned subsidiary, Kremers Urban Pharmaceuticals. Through our Silarx subsidiary, we are developing a fuller line of OTC products. We expect to launch our OTC Lansoprazole product sometime in the future."
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 Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg, and Lansoprazole Delayed-Release Capsules USP, 15 mg (OTC), and the planned launches 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 Co., LLC
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SOURCE Lannett Company, Inc.