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.