Amneal Announces Approval of Generic Version of Amicar®
September 05 2019 - 9:25AM
Business Wire
- Company granted 180 days of exclusivity under
FDA Competitive Generic Therapy approval pathway -
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today
announced that it has received approval from the U.S. Food and Drug
Administration (FDA) for its generic version of Amicar®
(aminocaproic acid oral solution) 0.25g/mL.
Amneal was previously granted a Competitive Generic Therapy
(CGT) designation for its generic version of Amicar® by the FDA. As
the first approved application, Amneal has been granted 180 days of
CGT exclusivity.
“We are pleased to be able to utilize the FDA’s Competitive
Generic Therapy approval pathway to provide patients with expanded
access to a product with limited competition,” said Chintu Patel,
Co-CEO of Amneal. “Going forward, we will continue to leverage our
development and regulatory expertise to take advantage of similar
opportunities and expand competition and patient access to
important generic medicines.”
According to IQVIA™, U.S market annual sales for the 12 months
ended June 30, 2019 for aminocaproic acid oral solution was
estimated to be approximately $28 million.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is an integrated pharmaceutical company focused on
developing, manufacturing and distributing generic, brand and
biosimilar 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 more than 300 generic
medicines and is expanding its portfolio to include complex dosage
forms 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
disorders and parasitic infections. For more information, visit
www.amneal.com.
Safe Harbor Statement
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). 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 Pharmaceuticals, Inc. (the “Company”). Such
risks and uncertainties include, but are not limited to: ; the
commercial success of our generic version of Amicar®; our ability
to successfully develop and commercialize new products; our ability
to obtain exclusive marketing rights for our products and to
introduce products on a timely basis; the competition we face in
the pharmaceutical industry from brand and generic drug product
companies, and the impact of that competition as well as
consolidation of institutional buyers and payers on our ability to
set prices; our ability to manage our growth; our dependence on the
sales of a limited number of products for a substantial portion of
our total revenues; the risk of product liability and other claims
against us by consumers and other third parties; risks related to
changes in the regulatory environment, including United States
federal and state laws related to healthcare fraud abuse and health
information privacy and security and changes in such laws; changes
to FDA product approval requirements; risks related to federal
regulation of arrangements between manufacturers of branded and
generic products; the impact of healthcare reform and changes in
coverage and reimbursement levels by governmental authorities and
other third-party payers; the continuing trend of consolidation of
certain customer groups; our reliance on certain licenses to
proprietary technologies from time to time; our dependence on third
party suppliers and distributors for raw materials for our products
and certain finished goods; the impact of global economic
conditions; our dependence on third party agreements for a portion
of our product offerings; our ability to make acquisitions of or
investments in complementary businesses and products on
advantageous terms; legal, regulatory and legislative efforts by
our brand competitors to deter competition from our generic
alternatives; the significant amount of resources we expend on
research and development; our substantial amount of indebtedness
and our ability to generate sufficient cash to service our
indebtedness in the future, and the impact of interest rate
fluctuations on such indebtedness; the high concentration of
ownership of our common stock and the fact that we are controlled
by a group of stockholders. A further 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, 2018, 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.
Trademarks referenced herein are the property of their
respective owner.
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