Navigation Links
ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay(TM)
Date:3/8/2010

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 http://www.istavision.com/.

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

RELATED LINKS
http://www.istavision.com

'/>"/>

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. WallSt.net (www.wallst.net) 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:
*Name:
*Comment:
*Email:
(Date:8/14/2017)... Israel , Aug. 15, 2017 /PRNewswire/ ... of adult stem cell technologies for neurodegenerative diseases, announced ... 2017. "We are ... Phase 3 trial to investigate NurOwn ® in ... Executive Officer of BrainStorm. "We have agreements with Mass. ...
(Date:8/10/2017)... , Aug. 10, 2017  Physical Rehabilitation Network (PRN), acquired ... Lakewood, Colorado . The reputable clinic will ... , PT, DPT with his staff of four clinicians. Lipkin ... Pittsburgh and brings over 10 years of experience with a ... Belmar PT marks the 10th PRN clinic in and around ...
(Date:8/8/2017)...   Second-quarter 2017 revenues of ... share from continuing operations ... to $110 million Second-quarter ... million Second-quarter 2017 adjusted ... 8 percent to $0.93 ...
Breaking Medicine Technology:
(Date:8/22/2017)... ... ... Star Glass is new to the Texas market, but is proudly managed by widely recognized ... and models, in Grand Prairie, TX, located in the center of the DFW Metroplex, the ... business for the past 40 years with 32 convenient locations in Texas, Nevada and California ...
(Date:8/22/2017)... ... August 22, 2017 , ... “Covert Awakening”: ... creation of published author, Julianne Hale, a consultant for the Intelligence Community. ... expert focusing on the Near East region. Julianne has written hundreds of ...
(Date:8/22/2017)... ... 22, 2017 , ... “Call Of Spiritual Duty”: a revelation in an era ... C.S. Lizarde. Growing up on the streets of North Visalia, California, Carlos Lizarde ... apply the Biblical keys to his life, he noticed immediately that opportunities and blessings ...
(Date:8/21/2017)... ... August 22, 2017 , ... The ... as a 2017-2018 inductee into its VIP Woman of the Year Circle. She ... nation’s leading networking organization exclusively for professional women, boasting more than 850,000 members, ...
(Date:8/21/2017)... , ... August 21, 2017 , ... Five chefs from ... awareness for Alzheimer’s Family Center. , Guests will be able to vote for ... Plaza, Braised Lamb Shank with Fennel Dill Salad, Feta Cheese Sauce & Garlic Pita ...
Breaking Medicine News(10 mins):