LAVAL, Quebec, Aug. 15, 2018 /PRNewswire/ -- Ortho
Dermatologics, a division of Bausch Health Companies Inc.
(NYSE/TSX: BHC), today announced it has resubmitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for DUOBRII™1 (halobetasol propionate and
tazarotene) (IDP-118) lotion in the treatment of plaque
psoriasis.
"After meeting with the FDA and understanding the additional
pharmacokinetic data required for DUOBRII, we have resubmitted the
NDA ahead of schedule," said Joseph C.
Papa, chairman and CEO, Bausch
Health. "We continue to have confidence in an approval of
DUOBRII and hope to bring forward this important new treatment
option for those who suffer from plaque psoriasis as quickly as
possible."
If approved, DUOBRII will be the first and only topical lotion
that contains a unique combination of halobetasol propionate and
tazarotene in one formulation for the treatment of plaque psoriasis
in adult patients, allowing for a potentially expanded duration of
use.
About Ortho Dermatologics
Ortho Dermatologics, a Bausch Health 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 actinic keratosis, acne, atopic dermatitis, cold sores,
athlete's foot, nail fungus and other dermatoses. The Ortho
Dermatologics portfolio includes several leading acne, antifungal
and anti-infective products. More information can be found at
www.ortho-dermatologics.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company
whose mission is to improve people's lives with our health care
products. We develop, manufacture and market a range of
pharmaceutical, medical device and over-the-counter products,
primarily in the therapeutic areas of eye health, gastroenterology
and dermatology. We are delivering on our commitments as we build
an innovative company dedicated to advancing global health. More
information can be found at www.bauschhealth.com.
Forward-looking Statements
This news 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 the Company's other filings with the Securities and
Exchange Commission and the Canadian Securities Administrators,
which factors are incorporated herein by reference. In addition,
certain material factors and assumptions have been applied in
making these forward-looking statements, including that the risks
and uncertainties outlined above will not cause actual results or
events to differ materially from those described in these
forward-looking statements. The Company believes that the material
factors and assumptions reflected in these forward-looking
statements are reasonable, but 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. Bausch
Health undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this news release or to reflect actual outcomes, unless
required by law.
1 Provisional name
DUOBRII is a trademark of Ortho Dermatologics' affiliated
entities.
© 2018 Bausch Health Companies Inc.
Investor
Contact:
|
Media
Contact:
|
Arthur
Shannon
|
Kristy
Marks
|
arthur.shannon@bauschhealth.com
|
Kristy.Marks@bausch.com
|
(514)
856-3855
|
(908)
827-0683
|
(877) 281-6642 (toll
free)
|
|
View original content with
multimedia:http://www.prnewswire.com/news-releases/ortho-dermatologics-resubmits-us-new-drug-application-for-duobrii-halobetasol-propionate-and-tazarotene-lotion-300697693.html
SOURCE Bausch Health Companies Inc.