Amneal Receives Abbreviated New Drug Application Approval for EluRyng™, the First Generic NuvaRing®
December 12 2019 - 6:59AM
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 EluRyng™ (etonogestrel/ethinyl estradiol
vaginal ring), the first generic version of NuvaRing®. Amneal has
initiated commercialization activities for EluRyng, which is being
manufactured internally and launching today.
“We are pleased to announce FDA approval of EluRyng, one of 15
new, complex products we expect to launch over the next 18 to 24
months,” said Chirag and Chintu Patel, Co-Chief Executive Officers.
“This milestone underscores Amneal’s deep scientific and regulatory
capabilities and our ability to overcome significant barriers to
entry, including complex formulation development and specialized
manufacturing requirements. In addition, EluRyng adds a
differentiated, complex dosage form to our portfolio, and bringing
this product to market reflects our commitment to improving
affordable access to complex drug products. Looking ahead, we
remain enthusiastic about the additional high-value opportunities
in our pipeline that are designed to improve the lives of patients
and drive meaningful growth and value-creation for our shareholders
and other stakeholders in 2020 and beyond.”
According to IQVIA™, a leading healthcare data and analytics
provider, NuvaRing U.S. annual sales for the 12 months ended
October 31, 2019 were approximately $976 million.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is a fully-integrated pharmaceutical company
focused on the development, manufacture and distribution of generic
and specialty drug products. The Company has manufacturing
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, 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. 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). 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 NuvaRing; our ability
to successfully develop and commercialize new products; 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 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; 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 dependence on third
party suppliers and distributors for raw materials for our products
and certain finished goods; the impact of global economic
conditions; and legal, regulatory and legislative efforts by our
brand competitors to deter competition from our generic
alternatives. 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.
NuvaRing® is a registered trademark of Merck.
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Amneal Todd Branning Chief Financial Officer
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Amneal Pharmaceuticals (NYSE:AMRX)
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