DUBLIN, Dec. 31, 2018 /CNW/ -- Endo
International plc ("Endo"; NASDAQ: ENDP) today announced that, due
to the ongoing federal government shutdown, the U.S. Food and Drug
Administration (the "FDA") has requested a further stay of Endo's
ongoing litigation against the FDA for the duration of the
shutdown. That litigation challenges the FDA's authorization
of the bulk compounding of drugs, including vasopressin, that have
not satisfied the legal requirements under Section 503B of the Drug Quality and Security Act
amendments to the Federal Food, Drug, and Cosmetic Act. One
of Endo's subsidiaries, Par Sterile Products, LLC ("Par"),
manufacturers the only vasopressin product currently approved by
the FDA, Vasostrict®. The suit was most recently
stayed until December 31, 2018 and
the FDA had committed to use its best efforts to issue a final
clinical need determination for vasopressin on or before that
date. The FDA has now filed a motion, which Endo did not
oppose, seeking a further stay of the suit for the period of time
in which the government lacks appropriations. According to
the FDA's motion, absent an appropriation, Department of Justice
attorneys and the FDA employees responsible for handling Endo's
litigation and the clinical need determination, respectively, are
prohibited from working, even on a voluntary basis, except in very
limited circumstances. If the FDA's motion is granted, the
litigation will be stayed for as long as the appropriations lapse
continues and Endo is not at this time aware when appropriations
may resume.
Two Endo subsidiaries, Par and Endo Par Innovation Company, LLC,
sued the FDA in the U.S. District Court for the District of Columbia in October 2017 challenging the agency's "Interim
Policy" on bulk compounding under Section 503B as unlawful because it authorized bulk
compounding of drugs, including vasopressin, where the applicable
legal requirements (including a determination of clinical need)
were not satisfied. In January
2018 and March 2018, the
parties agreed to stay the case while the FDA took initial steps to
comply with the statutory framework. The parties then agreed
in September 2018 to another stay of
the litigation based on the FDA's representation that it would use
its best efforts to finalize its clinical need determination for
vasopressin by December 31,
2018. Endo and other interested parties have submitted
comments on the FDA's proposed vasopressin determination. In
light of the appropriations lapse, however, that determination will
now not occur by December 31,
2018.
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,
statements relating to the status and outcome of litigation and 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