PDUFA Date Set for February 25, 2019
LAVAL, Quebec, July 9, 2018 /PRNewswire/ -- – Bausch +
Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International, Inc.
(NYSE/TSX: VRX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for
its sub-micron loteprednol etabonate ophthalmic gel, 0.38% with a Prescription Drug User Fee Act (PDUFA) action date of
February 25, 2019. If approved, the product would be the lowest concentrated loteprednol ophthalmic
corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
"The sub-micron loteprednol etabonate ophthalmic gel, 0.38% will offer eye care professionals and their patients a lower
concentration formulation with less frequent dosing compared to currently available formulations of loteprednol," said
Tracy Valorie, senior vice president, U.S. Pharmaceuticals and Surgical, Bausch + Lomb. "We are
committed to developing innovative ophthalmic treatment options to help serve the needs of patients and look forward to bringing
this new product to market."
This investigative product utilizes a novel submicron particle to help increase ocular penetration and residence time in
anterior segment tissues.
About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading
global eye health organization that is solely focused on protecting, enhancing and restoring people's eyesight. Its core
businesses include over-the-counter supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care
products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures and markets one of the most
comprehensive product portfolios in the industry, which is available in more than 100 countries.
About Valeant
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) 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.valeant.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," "look forward," "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 Valeant'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 news release or to reflect actual
outcomes, unless required by law.
© 2018 Bausch & Lomb Incorporated
LOT.0015.USA.18
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SOURCE Bausch + Lomb