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ISTA Pharmaceuticals Submits Supplemental New Drug Application to

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surf1944   Thursday, 12/17/09 04:37:20 PM
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ISTA Pharmaceuticals Submits Supplemental New Drug Application to the FDA for Once-Daily XiDay(TM)

Press Release Source: ISTA Pharmaceuticals, Inc. On Thursday December 17, 2009, 4:01 pm

IRVINE, Calif., Dec. 17 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced the Company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery. ISTA currently markets Xibrom™ (bromfenac ophthalmic solution) 0.09%, which is an eye drop labeled for use twice-daily, beginning 24 hours after cataract surgery. If approved, ISTA plans to market the once-daily product under the brand name XiDay™.

ISTA filed the XiDay sNDA electronically in eCTD format. Pending FDA validation of the electronic file in the coming days and timely acceptance of the filing by the FDA, ISTA expects a standard review of six months from date of receipt.

Xibrom™ (bromfenac ophthalmic solution

Xibrom is a topical 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 is the 2009 year-to-date dollar market share leader in the U.S. ophthalmic non-steroidal anti-inflammatory market. ISTA reported Xibrom net sales of $55.1 million for the nine-month period ended September 30, 2009.

Xibrom currently is labeled as an eye drop used twice-daily beginning 24 hours after cataract surgery. Xibrom has not been approved by the FDA as a once-daily treatment. ISTA's sNDA filing requests the Agency approve a change to bromfenac ophthalmic solution's label to reflect its efficacy as a once-daily treatment in this patient population.



surf's up......crikey



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