PDUFA Date Set for Oct. 5,
2018
JEMDEL Studied for Up to Eight Weeks of Use
LAVAL, Quebec, Feb. 14, 2018 /PRNewswire/ -- 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) accepted the New Drug
Application for JEMDEL™1 (halobetasol propionate 0.01%)
(IDP-122) lotion with a PDUFA action date of Oct. 5, 2018. If approved, JEMDEL will be the
first high-potency topical steroid treatment for plaque psoriasis
with dosing for as long as eight weeks. In the clinical trials, the
most common adverse event was upper respiratory tract
infection.
"The impact of psoriasis can be devastating for the millions of
patients who live with the pain and stigma of this lifelong chronic
condition," said Joseph C. Papa,
chairman and CEO, Valeant. "If approved, we believe JEMDEL will be
an important option for patients with plaque psoriasis."
Psoriasis is a chronic, painful and frequently life-altering
immune-mediated inflammatory skin disease associated with serious
comorbidities and substantial impairment of physical and
psychological quality of life. More than 75% of patients with
moderate-to-severe plaque psoriasis experience significant itching,
and greater than 55% report moderate or worse levels of
pain.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.
© 2018 Valeant Pharmaceuticals North America LLC
VNP.0060.USA.17
1 Provisional Name
2 World Health Organization Global Report on
Psoriasis
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)
|
|
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SOURCE Valeant Pharmaceuticals International, Inc.