PHILADELPHIA, Jan. 13, 2020 /PRNewswire/ -- Lannett
Company, Inc. (NYSE: LCI) today announced that the U.S. Food and
Drug Administration (FDA) has approved the New Drug Application
(NDA), submitted under the 505(b)(2) regulatory pathway, for
Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL), the
company's branded local anesthetic product.
"The FDA's approval of our Cocaine HCl product, the first NDA
approval to include full clinical trials in the company's history,
marks a major milestone in Lannett's 70+ years of operations," said
Tim Crew, chief executive officer of
Lannett. "We believe the product has the potential to be an
excellent option for the labeled indication. We expect to launch
the product shortly, under the brand name
NUMBRINO®."
NUMBRINO® (cocaine hydrochloride) nasal solution is
an ester local anesthetic indicated for the introduction of local
anesthesia of the mucous membranes for diagnostic procedures and
surgeries on or through the nasal cavities of adults. The 505(b)(2)
NDA submission was supported by two Phase III, randomized,
double-blind, placebo-controlled, multicenter studies in several
hundred patients, as well as a Phase I pharmacokinetic study.
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 NUMBRINO®,
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.