DUBLIN, Aug. 2, 2019 /CNW/ -- Endo International plc
("Endo") (NASDAQ: ENDP) today applauded the U.S. District Court for
the District of Columbia's
decision supporting the Food and Drug Administration's (FDA)
determination that vasopressin cannot be used for compounding by
outsourcing facilities. The Court specifically concluded that
the FDA's decision to exclude vasopressin from the "clinical need"
list was consistent with the applicable statutory scheme and was
otherwise not "arbitrary and capricious."
In March 2019, the FDA determined
that there is no clinical need to compound vasopressin under
Section 503B of the Drug Quality and
Security Act. As a result, it is unlawful for outsourcing
facilities to sell compounded vasopressin products unless they
manufacture those products using an FDA-approved vasopressin
product, rather than bulk vasopressin, or if vasopressin were to be
added to the FDA's drug shortage list. Par Sterile Products,
LLC ("Par"), a subsidiary of Endo, is the manufacturer of
Vasostrict®, the only vasopressin product approved by
the FDA. Following the FDA's decision, Athenex, Inc.
and two of its affiliates sued the FDA seeking to overturn
the vasopressin decision. Par and another Endo subsidiary
intervened as defendants in the action.
"At Endo, delivering high quality products and ensuring patient
safety are our top priorities and we are very pleased with the
district court's decision confirming the FDA's determination that
there is no clinical need to bulk compound vasopressin," said
Matthew J. Maletta, Executive Vice
President and Chief Legal Officer of Endo.
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused
generics and specialty branded pharmaceutical company delivering
quality medicines to patients in need through excellence in
development, manufacturing and commercialization. Endo has
global headquarters in Dublin,
Ireland, and U.S. headquarters in Malvern, PA. Learn
more at www.endo.com.
Cautionary Note Regarding Forward-Looking Statements
Certain information in this press release may be considered
"forward-looking statements," within the meaning of the Private
Securities Litigation Reform Act of 1995 and any applicable
Canadian securities legislation including, but not limited to, the
statements by Mr. Maletta and other statements relating to the
status and outcome of litigation and the potential impact of the
FDA's clinical need determination for vasopressin. All
forward-looking statements in this press release reflect Endo's
current expectations of future events based on information
available to Endo as of the date of this press release. If
underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially
from Endo's expectations and projections. Risks and
uncertainties include, among other things, general industry and
market conditions; technological advances and patents attained by
competitors; challenges inherent in the research and development
and regulatory processes, including regulatory decisions, product
recalls, withdrawals and other unusual items; challenges related to
product marketing, such as the unpredictability of market
acceptance for new products and/or the acceptance of new
indications for such products; inconsistency of treatment results
among patients; potential difficulties in manufacturing; the
outcome of litigation, settlement discussions or other adverse
proceedings; general economic conditions; and governmental laws and
regulations affecting domestic and foreign operations. Endo
expressly disclaims any intent or obligation to update these
forward-looking statements except as required by law. Additional
information concerning these and other risk factors can be found in
Endo's periodic reports filed with the U.S. Securities and Exchange
Commission and in Canada on the
System for Electronic Data Analysis and Retrieval, including
current reports on Form 8-K, quarterly reports on Form 10-Q and
annual reports on Form 10-K.
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SOURCE Endo International plc