LAVAL, Quebec, Sept. 30, 2014 /PRNewswire/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today
announced that the company's Bridgewater,
New Jersey location received a Warning Letter from the U.S.
Food and Drug Administration (FDA) relating to an inspection in
June 2014 of the Company's records
with regards to Sculptra Aesthetic injectable, which was divested
to Galderma S.A. in July 2014. The
Warning Letter pertains to the management of Valeant's
contract manufacturers (rather than Valeant's own internal
manufacturing) with regard to some specific Good Manufacturing
Practice (GMP) activities, including review and documentation of
supplier's deviation reports prior to batch release and performing
corrective and preventive action (CAPA) effectiveness checks
as required by procedure. The warning letter does not prevent the
manufacturing or distribution of Sculptra nor the manufacture or
distribution of any of Valeant's products, and does not relate to
the pending review of any Bausch + Lomb compounds.
Valeant takes all correspondence from the FDA seriously and will
be responding to the agency with our improved system and procedure
implementations to address the FDA's concerns shortly. As the
issues referenced by the FDA were never at any time regarding the
manufacturing quality or safety of any product, we believe that we
will be able to resolve this matter in a timely fashion.
About Valeant Pharmaceuticals International, Inc.
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, 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,
including, but not limited to, statements regarding improved system
and procedure implementation and the ability resolve this matter in
a timely fashion. Forward-looking statements may be
identified by the use of the words "anticipates," "expects,"
"intends," "plans," "should," "could," "would," "may," "will,"
"believes," "estimates," "potential," 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 filed with the Securities and Exchange
Commission ("SEC") and other risks and uncertainties detailed from
time to time in the Company's filings with the SEC 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. 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.
Contact Information:
Valeant
Pharmaceuticals:
Investors:
Laurie W. Little
Valeant Pharmaceuticals International, Inc.
949-461-6002
laurie.little@valeant.com
Logo -
http://photos.prnewswire.com/prnh/20101025/LA87217LOGO
SOURCE Valeant Pharmaceuticals International, Inc.