LAVAL, Quebec, Aug. 7, 2017 /CNW/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today
announced it has received a Complete Response Letter (CRL) from the
U.S. Food and Drug Administration (FDA) regarding the New Drug
Application (NDA) for latanoprostene bunod ophthalmic solution,
0.024%, an investigative intraocular pressure lowering single-agent
eye drop for patients with open angle glaucoma or ocular
hypertension.
The CRL from the FDA only refers to a Current Good Manufacturing
Practice (CGMP) inspection at Bausch + Lomb's manufacturing
facility in Tampa, Fla. The FDA
did not identify any efficacy or safety concerns with respect to
the NDA or additional clinical trials needed for the approval of
the NDA for latanoprostene bunod ophthalmic solution, 0.024%.
Valeant will work closely with the FDA to determine the
appropriate next steps for the NDA.
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", "if approved",
"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 Contacts:
Arthur
Shannon
arthur.shannon@valeant.com
514-856-3855
877-281-6642 (toll
free)
Media Contact:
Lainie
Keller
lainie.keller@valeant.com
908-927-0617
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SOURCE Valeant Pharmaceuticals International, Inc.