PDUFA Date Is Aug. 27,
2018
LAVAL, Quebec, Jan. 12, 2018 /CNW/ -- Ortho Dermatologics,
a division of Valeant Pharmaceuticals International, Inc. (NYSE:
VRX and TSX: VRX) ("Valeant") , today announced that the U.S. Food
and Drug Administration (FDA) has accepted the New Drug Application
for IDP-121 (tretinoin 0.05%) lotion
(ALTRENO™1) with a PDUFA action date of
Aug. 27, 2018. If approved, ALTRENO
will be the first tretinoin product in lotion form rather than a
gel or cream.
"More than 4 million patients make appointments with
dermatologists each year for acne. It is our goal to be the go-to
resource for doctors and patients for all dermatological
conditions, and if approved, ALTRENO will be a valuable addition to
the Ortho Dermatologics portfolio," said Joseph C. Papa, chairman and CEO, Valeant.
Acne, also known as acne vulgaris, is the most common skin
disease in the United States, and
as many as 50 million people in the
United States may have the disease.2
About Ortho Dermatologics
Ortho Dermatologics, a
Valeant Pharmaceuticals International, Inc. company, is one of the
largest prescription dermatology businesses in the world dedicated
to helping patients in the treatment of a range of therapeutic
areas, including psoriasis, actinic keratosis, acne, atopic
dermatitis and other dermatoses. The Ortho Dermatologics
portfolio includes several leading acne, anti-fungal and
anti-infective products. More information can be found at
www.ortho-dermatologics.com.
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.
Contact
Information:
|
Media
Contact:
|
Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@valeant.com
|
lainie.keller@valeant.com
|
514-856-3855
|
908-927-0617
|
877-281-6642 (toll
free)
|
|
1 Provisional name
2 White GM. Recent findings in the epidemiologic
evidence, classification, and subtypes of acne vulgaris. J Am Acad
Dermatol. 2004;39:S34-37
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SOURCE Valeant Pharmaceuticals International, Inc.