Navigation Links
ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay(TM)

IRVINE, Calif., March 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay™ (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.

Xibrom™ (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

Xibrom (bromfenac ophthalmic solution)® 0.09%, and XiDay™ 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.

SOURCE ISTA Pharmaceuticals, Inc.

Back to top



SOURCE ISTA Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. ( Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
(Date:11/25/2015)... Developmental, commercial, and regulatory/legal strategies ... products, says GBI Research . ... all play a key role in boosting the profitability of ... --> Developmental, commercial, and regulatory/legal ... profitability of pharmaceutical products, says GBI Research ...
(Date:11/24/2015)... 2015 The hope of bearing ... of IVF cycles. After failure of over 15 IVF ... lost all hopes that she would be able to conceive ever. But finally optimism prevailed ... after failure of over 15 IVF cycles. ... to take one last attempt with Gaudium IVF Center in ...
(Date:11/24/2015)... HILL, N.C. , Nov. 24, 2015  In ... research projects in an effort to quickly uncover new ... position. --> --> ... launch a market research project and ensure that all ... company and industry standards. Another major barrier to efficiently ...
Breaking Medicine Technology:
(Date:11/25/2015)... , ... November 25, 2015 , ... On November 23rd ... Tri Lite’s personal heating products business. Cozy Products explains what this means ... that fit in well with the Cozy Products business model: to sell personal heaters ...
(Date:11/25/2015)... ... ... SCOTTSDALE, AZ) - Today, Dr. Todd C. Hobgood ... non-surgical treatments, announced the expansion of his private practice capabilities with the grand ... trained and nationally recognized for his natural approach, Dr. Todd Hobgood serves the ...
(Date:11/25/2015)... ... November 25, 2015 , ... Brillianteen, McGaw YMCA’s student-produced musical ... its 65th Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions for this ... Brillianteen has been a treasured tradition for numerous families in the Evanston community. ...
(Date:11/25/2015)... ... November 25, 2015 , ... “While riding the bus, I saw a passenger ... thought there had to be a convenient and comfortable way to protect them from ... disabled individuals to safely travel during cold or inclement weather. In doing so, it ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... provide scholarships for people struggling with eating disorders as a result of the ... second annual event, held at Fox Run Golf Club in Eureka, will help ...
Breaking Medicine News(10 mins):