Amneal Receives Abbreviated New Drug Application Approval for Lidocaine Patch, 5%
August 25 2020 - 9:00AM
Business Wire
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced that it has received Abbreviated New
Drug Application (ANDA) approval from the U.S. Food and Drug
Administration (FDA) for a generic version of Lidocaine Patch, 5%.
Lidocaine Patch, 5% is the generic version of Lidoderm Patch, 5%
for treatment of post-herpetic neuralgia.
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“We are pleased to announce the approval for the Lidocaine
Patch, 5%, which will be Amneal’s first commercialized hydrogel
product,” said Chirag and Chintu Patel, Co-Chief Executive
Officers. “This is our 8th of the 15 complex products we expect to
launch by August 2021, further reinforcing our confidence in our
extensive pipeline and global manufacturing capabilities. Amneal
has expertise in both Matrix-based as well as Hydrogel-based
patches, which are manufactured at our Piscataway, NJ site.”
According to IQVIA™, a leading healthcare data and analytics
provider, U.S. annual sales for Lidocaine Patch, 5% for the 12
months ended June 2020 were approximately $282 million.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is a fully-integrated pharmaceutical company
focused on the development, manufacturing and distribution of
generic and specialty drug products. The Company has operations in
North America, Asia, and Europe, working together to bring
high-quality medicines to patients primarily within the United
States.
Amneal has an extensive portfolio of approximately 250 product
families and is expanding its portfolio to include complex dosage
forms, including biosimilars, in a broad range of therapeutic
areas. The Company also markets a portfolio of branded
pharmaceutical products through its Specialty segment focused
principally on central nervous system and endocrine disorders.
The Company also owns 65% of AvKARE. AvKARE provides
pharmaceuticals, medical and surgical products and services
primarily to governmental agencies, primarily focused on serving
the Department of Defense and the Department of Veterans Affairs.
AvKARE is also a packager and wholesale distributor of
pharmaceuticals and vitamins to its retail and institutional
customers who are located throughout the United States focused
primarily on offering 340b-qualified entities products to provide
consistency in care and pricing. For more information, visit
www.amneal.com.
Forward-Looking Statements
Certain statements contained herein, regarding matters that are
not historical facts, may be forward-looking statements (as defined
in the Private Securities Litigation Reform Act of 1995, as
amended). Such forward-looking statements include statements
regarding management’s intentions, plans, beliefs, expectations or
forecasts for the future, including, among other things, future
operating results and financial performance, product development
and launches, integration strategies and resulting cost reduction,
market position and business strategy. Words such as “may,” “will,”
“could,” “expect,” “plan,” “anticipate,” “intend,” “believe,”
“estimate,” “assume,” “continue,” and similar words are intended to
identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking
statements. These forward-looking statements are based on current
expectations of future events. If the underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of Amneal. A list and descriptions of these risks,
uncertainties and other factors can be found in the Company’s most
recently filed Annual Report on Form 10-K for the fiscal year ended
December 31, 2019, as supplemented by any subsequently filed
Quarterly Reports on Form 10-Q. Copies of these filings are
available online at www.sec.gov, www.amneal.com or on request from
the Company.
Forward-looking statements included herein speak only as of the
date hereof and we undertake no obligation to revise or update such
statements to reflect the occurrence of events or circumstances
after the date hereof, except as otherwise required by United
States securities laws.
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version on businesswire.com: https://www.businesswire.com/news/home/20200825005601/en/
Tasos Konidaris EVP, Chief Financial Officer
invest@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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