LAVAL, Quebec, Aug. 16, 2017 /CNW/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX)
("Valeant" or the "Company") today announced the U.S. Food and Drug
Administration (FDA) confirmed it intends to issue a Voluntary
Action Indicated (VAI) inspection classification for its Bausch +
Lomb manufacturing facility in Tampa,
Fla. as part of a forthcoming Establishment Inspection
Record for the facility. With this confirmation, manufacturing
uncertainties related to current and upcoming regulatory
submissions will be eliminated for products manufactured at the
Tampa facility.
"Following continued close collaboration with FDA inspectors,
today, the FDA confirmed that all issues related to a Current Good
Manufacturing Practice inspection at the Tampa facility are being satisfactorily
resolved, and VAI status will soon be granted to the facility. We
expect this to facilitate our current and upcoming regulatory
submissions of products manufactured at the facility," said
Joseph C. Papa, chairman and CEO,
Valeant.
As further evidence of the progress made at the Tampa facility, the Company received approval
yesterday for a Supplemental New Drug Application for the facility
to be a release testing facility for drug substance for Alaway®
(ketotifen fumarate ophthalmic solution), 0.035%.
A VAI inspection classification occurs when objectionable
concerns were observed by FDA inspectors at a facility, but the
problems do not meet the threshold of regulatory
significance.1
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.
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1 https://www.fda.gov/downloads/aboutfda/transparency/publicdisclosure/glossaryofacronymsandabbreviations/ucm212061.pdf
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:
|
Media
Contact:
|
Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@valeant.com
|
lainie.keller@valeant.com
|
(514)
856-3855
|
(908)
927-0617
|
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SOURCE Valeant Pharmaceuticals International, Inc.