DUBLIN, Aug. 15, 2018 /PRNewswire/ -- Endo
International plc (NASDAQ: ENDP) today announced that it is lifting
a temporary stay of its litigation against the U.S. Food and Drug
Administration (FDA). The litigation, filed in the U.S.
District Court for the District of
Columbia in October 2017 by
the Company's subsidiaries, Par Sterile Products, LLC and Endo Par
Innovation Company, LLC (collectively, "Endo"), seeks a declaration
that FDA's "Interim Policy" on compounding using bulk drug
substances under Section 503B of the
Drug Quality and Security Act of 2013 (DQSA) amendments to the
Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to law
because it authorizes bulk compounding of new drugs where the
applicable DQSA requirements are not satisfied and because it is
fundamentally inconsistent with the plain language and structure of
the FDCA statutory regime for introducing new drugs. The
litigation also seeks the immediate removal of vasopressin from
FDA's Category 1 nominations list to assure that outsourcing
facilities do not engage in bulk compounding of
vasopressin-containing drug products under Section 503B.
In light of an outsourcing facility's recent announcement that
it has launched a ready-to-use vasopressin product compounded using
bulk drug substances under Section 503B, Endo is lifting the stay of its litigation
against FDA. "Bulk compounding of vasopressin under Section
503B is inappropriate and undermines
the longstanding new drug approval framework of the Federal Food,
Drug, and Cosmetic Act," said Matthew J.
Maletta, Executive Vice President and Chief Legal Officer of
Endo. "We previously stated that in the event an entity were to
commence bulk compounding of vasopressin under Section 503B prior to FDA's implementation of a new
compounding policy, we would lift the stay of our litigation
against FDA. Yesterday we did just that, and we will file a motion
for preliminary injunction vacating the listing of vasopressin on
FDA's Category 1 bulk drug substances list and preventing FDA from
authorizing bulk compounding using vasopressin in a manner that
does not comply with applicable laws."
In January 2018, following public
statements from FDA reflecting FDA's intent to alter its
compounding policy, and after discussions among the parties'
counsel, Endo agreed to FDA's request to stay the parties'
litigation until March 30,
2018. Under the terms of the litigation stay, Endo retained
the ability to terminate the stay by notifying FDA that it believes
that an entity has commenced or is likely to commence bulk
compounding of any vasopressin-containing drug product under
Section 503B. Endo later agreed
to extend the temporary litigation stay for an additional 180 days
following FDA's issuance in March
2018 of draft guidance describing the procedures that FDA
intends to follow, and the criteria that FDA intends to apply, in
implementing the requirements of the DQSA for use of bulk drug
substances in compounding under Section 503B. In the draft guidance, FDA states,
among other things, that because "compounded drug products are
subject to a lower regulatory standard than FDA-approved drugs,
they should only be used by patients whose medical needs cannot be
met by an FDA-approved drug." FDA further explains that in
certain situations, "compounding using the FDA-approved drug
product instead of a bulk drug substance would meet patients'
medical needs and present less risk," and specifically describes
the dilution of FDA-approved drugs by outsourcing facilities to
produce intravenous bags for hospitals as such a situation.
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," including, but not limited to, the
statements by Mr. Maletta. 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 ("SEDAR"), including current reports on Form
8-K, quarterly reports on Form 10-Q and annual reports on Form
10-K.