LANNETT TO PRESENT AT THE 34th ANNUAL ROTH CONFERENCE ON MARCH 14
Lannett Company (NYSE: LCI) will participate in the 34th Annual ROTH Conference on March 14, 2022, at 12:30 p.m. PT in Laguna Niguel, California. The company plans to discuss its product development portfolio, particularly the status of its ANDA for generic Advair Diskus, which has received a Complete Response Letter (CRL) from the FDA. Lannett intends to request a meeting with the FDA to clarify the issues raised. A webcast of the presentation will be available on their website, with an archive accessible for 90 days.
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TREVOSE, Pa., March 4, 2022 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that the company will participate in a fireside chat at the 34th Annual ROTH Conference on March 14, 2022 at 12:30 p.m. PT at The Ritz Carlton, in Laguna Niguel, California. The company expects to provide an update on its product development portfolio, including the status of its pending Abbreviated New Drug Application (ANDA) for generic Advair Diskus® - additional information below.
A webcast of the presentation will be available at www.lannett.com. Listeners are encouraged to visit the web site at least 10 minutes prior to the start of the presentation to register, download and install any necessary software. The presentation will be archived and accessible on the web site for 90 days.
Regarding its ANDA for generic Advair Diskus®, the company said that, as expected, it has received a CRL from the U.S. Food and Drug Administration (FDA). A CRL is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the ANDA in its current form. The company intends to ask the FDA for a post-CRL meeting to clarify and better understand the FDA's questions, comments and requests. The company noted that the FDA acknowledged it did not yet provide feedback on several of the company's more recently submitted amendments to the ANDA. Nevertheless, based on a preliminary review of the CRL, the company anticipates that at least a second review cycle of the ANDA will be required.
ADVAIR DISKUS® is a registered trademark of GlaxoSmithKline.
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, advancing the development of generic Advair Diskus, as well as timing and outcome of FDA approval and successfully commercializing the product, 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.
Contact: | Robert Jaffe |
Robert Jaffe Co., LLC | |
(424) 288-4098 |
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SOURCE Lannett Company, Inc.
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