ISTA Pharmaceuticals Receives PDUFA Action Date of October 16, 2010 for FDA Review of Once-Daily XiDay
IRVINE, Calif., March 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA - News), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDayTM (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has granted XiDay a standard review time of ten months, assigning ISTA a Prescription Drug User Fee Act (PDUFA) action date of October 16, 2010. ISTA's request for a shorter, six-month priority review is still under consideration by the FDA.
XibromTM (bromfenac ophthalmic solution)
ISTA currently markets Xibrom (bromfenac ophthalmic solution)® 0.09%. Xibrom is an eye drop formulation of a non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. 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. Xibrom was the 2009 dollar market share leader in the U.S. ophthalmic non-steroidal anti-inflammatory market. ISTA reported Xibrom net sales of $81.1 million for the year ended December 31, 2009.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is the fourth largest branded ophthalmic pharmaceutical business in the U.S. ISTA's four marketed products plus its product candidates include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company is developing a strong product pipeline to fuel future growth and market share, 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/.
Xibrom (bromfenac ophthalmic solution)® 0.09%, and XiDayTM are trademarks of ISTA Pharmaceuticals.
Forward-looking Statements
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to ISTA's belief that the FDA is considering a shorter review time of six months for XiDay, and ISTA's expectation of becoming the leading niche ophthalmic pharmaceutical company are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, delays and uncertainties related to the FDA or other regulatory agency approval or actions and such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2009.