Amneal Receives Abbreviated New Drug Application Approval for Acyclovir Cream, 5%
12 November 2020 - 12:35AM
Business Wire
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) today
announced that it has received approval for its Abbreviated New
Drug Application (ANDA) from the U.S. Food and Drug Administration
(FDA) for Acyclovir Cream, 5%. Acyclovir Cream, 5%, is the generic
version of Zovirax® for treatment of recurrent herpes labialis
(cold sores) in immunocompetent adults and adolescents 12 years of
age and older. The product is available by prescription only and is
associated with mild side effects such as nausea.
“Approval of our Acyclovir Cream, 5%, marks another milestone
along our path toward providing more accessible, complex generic
formulations to patients and to the U.S. healthcare system,” stated
Chirag and Chintu Patel, Co-Chief Executive Officers. “Acyclovir
Cream, 5%, represents one of our complex drug products launched
this year, which demonstrates the strength of our pipeline and the
depth of our manufacturing capabilities. This approval is a
precedent for Amneal as it is the first Topical Cream product to be
approved based on innovative scientific strategy, which also
demonstrates our technological advancements.”
According to IQVIA™, a leading healthcare data and analytics
provider, U.S. annual sales for Acyclovir Cream, 5%, for the 12
months ended September 2020 were approximately $67 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
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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 upon 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
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version on businesswire.com: https://www.businesswire.com/news/home/20201111005478/en/
Tasos Konidaris EVP, Chief Financial Officer
invest@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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