LAVAL, Quebec, May 17, 2017 /CNW/ -- Salix Pharmaceuticals,
Inc. and parent Valeant Pharmaceuticals International, Inc. (NYSE:
VRX and TSX: VRX) ("Valeant") and Actavis Laboratories, Inc., at
Actavis' request, have agreed to stay outstanding litigation and
extend the 30-month stay regarding Actavis' Abbreviated New Drug
application (ANDA) for a generic version of Xifaxan (rifaximin) 550
mg tablets.
Valeant initiated the litigation against Actavis on March 23, 2016. Additionally, Valeant filed
a Citizen Petition with the U.S. Food and Drug Administration (FDA)
on Oct. 17, 2016, requesting changes
to previously recommended standards for approval of generic
versions of Xifaxan. On March 16,
2017, the FDA answered the Citizen Petition and issued its
revised draft guidance regarding the recommended standards for
approval of ANDAs for generic versions of Xifaxan.
Legal action is stayed through April 30,
2018 and cannot be lifted prior to Oct. 31, 2017. All currently scheduled litigation
activities, including the January
2018 trial date, have been indefinitely removed from the
Court docket.
The parties agree and the Court ordered that Actavis' 30-month
regulatory stay shall be extended from Aug.
12, 2018 until no earlier than Feb.
12, 2019 and could be longer if the litigation stay lasts
for more than 6 months.
Valeant remains confident in the strength of the Xifaxan patents
and will defend its intellectual property vigorously.
About Valeant
Valeant Pharmaceuticals International,
Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical
company that develops, manufactures and markets a broad range of
pharmaceutical products primarily in the areas of dermatology,
gastrointestinal disorders, eye health, neurology and branded
generics. More information about Valeant can be found at
www.valeant.com.
Forward-looking Statements
This press release may
contain forward-looking statements which may generally be
identified by the use of the words "anticipates," "expects,"
"intends," "plans," "should," "could," "would," "may," "will,"
"believes," "estimates," "potential," "target," or "continue" and
variations or similar expressions. These statements are based upon
the current expectations and beliefs of management and are subject
to certain risks and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements. These risks and uncertainties include, but are not
limited to, risks and uncertainties discussed in the Company's most
recent annual or quarterly report and detailed from time to time in
Valeant's other filings with the Securities and Exchange Commission
and the Canadian Securities Administrators, which factors are
incorporated herein by reference. Readers are cautioned not to
place undue reliance on any of these forward-looking
statements. These forward-looking statements speak only as of
the date hereof. Valeant undertakes no obligation to update any of
these forward-looking statements to reflect events or circumstances
after the date of this press release or to reflect actual outcomes,
unless required by law.
Investor Contact:
Elif
McDonald
elif.mcdonald@valeant.com
514-856-3855
877-281-6642 (toll free)
Media Contact:
Lainie
Keller
lainie.keller@valeant.com
908-627-0917
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SOURCE Valeant Pharmaceuticals International, Inc.