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.
|SOURCE ISTA Pharmaceuticals, Inc.|
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