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ISTA Pharmaceuticals Submits New Drug Application for
Xibrom(TM) QD (once-daily)
IRVINE, Calif., Dec. 20 /PRNewswire-FirstCall/ -- ISTA
Pharmaceuticals, Inc. (Nasdaq: ISTA), announced today the
Company has submitted a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for Xibrom(TM) QD
(once-daily). The Company is seeking approval for Xibrom QD as a
treatment for inflammation, pain, and photophobia following
cataract surgery.
Xibrom(TM) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for
the treatment of ocular inflammation and pain. Xibrom, approved
in 2005, is the first and only FDA-approved twice-daily NSAID
for inflammation and reduction of pain following cataract
surgery. Xibrom is the fastest growing ophthalmic product in
2007, according to IMS data. Xibrom, under a different trade
name but identical formulation, was launched in Japan in 2000 by
Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing
rights for Xibrom in 2002 and launched the product in the U.S.
in 2005.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company.
ISTA's products and product candidates addressing the $3.2
billion U.S. prescription ophthalmic industry include therapies
for inflammation, ocular pain, glaucoma, allergy, and dry eye.
The Company currently markets three products and is developing a
strong product pipeline to fuel future growth and market share.
The Company's product development and commercialization strategy
is to launch a new product every 12 to 18 months, thereby
continuing its growth to become the leading niche ophthalmic
pharmaceutical company in the U.S. For additional information
regarding ISTA, please visit ISTA Pharmaceuticals' website at
http://www.istavision.com.
Contact
Vince Anido, +1-949-788-5311, vanido@istavision.com, or
Investors, Lauren Silvernail, +1-949-788-5302, lsilvernail@istavision.com,
both of ISTA Pharmaceuticals; Media, Justin Jackson, jjackson@burnsmc.com,
or
Investors, Juliane Snowden, +1-212-213-0006, jsnowden@burnsmc.com,
both of
Burns McClellan, for ISTA Pharmaceuticals
Source
ISTA Pharmaceuticals, Inc.
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