Navigation Links
ISTA Pharmaceuticals Submits Supplemental New Drug Application to the FDA for Once-Daily XiDay(TM)
Date:12/17/2009

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(TM) (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(TM).

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(TM) (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 populat
'/>"/>

SOURCE ISTA Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Vion Pharmaceuticals Files for Chapter 11 Bankruptcy
2. Optimer Pharmaceuticals to Present at the 28th Annual J.P. Morgan Healthcare Conference
3. Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Advanced Multiple Myeloma
4. Rib-X Pharmaceuticals Enters into Collaborative Agreement on Delafloxacin with Massachusetts General Hospital
5. Transcept Pharmaceuticals Receives Notice of Allowance for Second U.S. Patent Application Covering Intermezzo(R)
6. Vion Pharmaceuticals Receives Complete Response Letter for Onrigin(TM) From The U.S. Food And Drug Administration
7. Published Data Demonstrate Arena Pharmaceuticals Lorcaserin Has Low Abuse Potential
8. Onyx Pharmaceuticals to Webcast Analyst Briefing on Development Program
9. China Yongxin Pharmaceuticals, Inc. Announces Results for the Third Quarter Ended September 30, 2009
10. Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2010
11. Cubist Pharmaceuticals Becomes First Company to Implement Integrated Reprints Desk Document Delivery and QUOSA Scientific Literature Workflow Solution
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/31/2015)... , March 31, 2015 ANI Pharmaceuticals, Inc. ... of Propafenone Hydrochloride 150mg, 225mg and 300mg oral tablets, ... The overall US market for Propafenone Hydrochloride 150mg, 225mg ... IMS Health. Arthur S. Przybyl , ... to announce the launch of our fourth product from ...
(Date:3/31/2015)... Texas , March 31, 2015   Unique ... operational transformation is complete and the company has initiated ... "Our goal as a company is to ... Travis Leeah . "Meeting the new regulations is ... staff. We,re embracing the future of our industry, investing ...
(Date:3/31/2015)... , Mar. 27, 2015 Research and ... the addition of the "European Laboratory Information ... System), by Type (Clinical Pathology Laboratory Information System, ... 2019" report to their offering. ... to grow at a CAGR of 7.6% from ...
Breaking Medicine Technology:ANI Pharmaceuticals Announces the Launch of Propafenone Tablets 2ANI Pharmaceuticals Announces the Launch of Propafenone Tablets 3Unique Pharmaceuticals Launches Sterile Operations under New Federal Guidance 2Unique Pharmaceuticals Launches Sterile Operations under New Federal Guidance 3European Laboratory Information System Market Report 2015: Germany holds a larger share of the laboratory information systems market 2European Laboratory Information System Market Report 2015: Germany holds a larger share of the laboratory information systems market 3
... N.J., Feb. 15, 2011 Daiichi Sankyo, Inc. (DSI), ... facility in Bethlehem Township, Pennsylvania from Amcor, a global ... leverage existing resources to more cost-effectively supplement its operations ... expected to be operational in the summer or early ...
... MAHWAH, N.J., Feb. 15, 2011 Stryker Corporation,s Orthopaedics ... most recognizable names and personalities in professional golf, has ... of the sport and current member of the PGA ... Triathlon ® Knee System in November 2009 and ...
Cached Medicine Technology:Daiichi Sankyo, Inc. Acquires First US-Based Packaging and Manufacturing Facility 2Fred Funk Becomes Spokesperson for Stryker Orthopaedics 2Fred Funk Becomes Spokesperson for Stryker Orthopaedics 3
(Date:3/31/2015)... Former 49ers linebacker Chris Borland turned more heads with ... a promising NFL career. In a March episode of ... Leitch explores the curious case of Borland and the ... making process that Borland and other football players will likely ... paycheck, and what impact, if any, he thinks this case ...
(Date:3/31/2015)... National Adaptive Sports Month will ... benefits of participating in adaptive sports activities, educate ... athletes that adapt, believe and compete each week ... fitness and inclusive athletics in our schools, provide ... sports and advocate for an increase in the ...
(Date:3/31/2015)... Purchase, NY (PRWEB) March 31, 2015 ... to announce the presentation of new clinical study ... bonded arginine silicate (ASI), titled, “Arginine Silicate Supplementation ... and Increases Markers of Vasodilation and Cardiovascular Health ... to scientists and other professionals at the acclaimed ...
(Date:3/31/2015)... The New Jersey Chapter of the ... two administrators from Windsor Healthcare Communities, a leading ... Jersey, to two key leadership roles at this ... administrator for Abingdon Care & Rehabilitation Center of ... administrator of Canterbury Care & Rehabilitation Center at ...
(Date:3/31/2015)... 31, 2015 Williams Comfort Air ... visit when their home comfort is at stake. ... the visit fit into the customer’s schedule, a ... quality repair at requested times. , To ... customers in the Indianapolis area can visit ...
Breaking Medicine News(10 mins):Health News:Will Leitch and the Curious Case of Chris Borland on SCI TV 2Health News:Will Leitch and the Curious Case of Chris Borland on SCI TV 3Health News:April is National Adaptive Sports Month 2Health News:April is National Adaptive Sports Month 3Health News:Nutrition 21, LLC Announces the Presentation of Proteomic Results of a Nitrosigine® Clinical Study at the Renowned Experimental Biology 2015 Annual Meeting 2Health News:Nutrition 21, LLC Announces the Presentation of Proteomic Results of a Nitrosigine® Clinical Study at the Renowned Experimental Biology 2015 Annual Meeting 3Health News:Nutrition 21, LLC Announces the Presentation of Proteomic Results of a Nitrosigine® Clinical Study at the Renowned Experimental Biology 2015 Annual Meeting 4Health News:Nutrition 21, LLC Announces the Presentation of Proteomic Results of a Nitrosigine® Clinical Study at the Renowned Experimental Biology 2015 Annual Meeting 5Health News:Nutrition 21, LLC Announces the Presentation of Proteomic Results of a Nitrosigine® Clinical Study at the Renowned Experimental Biology 2015 Annual Meeting 6Health News:Abingdon Care & Rehabilitation Center’s Administrator Elected President of N.J. Chapter of the American College of Health Care Administrators 2Health News:Williams Comfort Air Launches Online Scheduling Tool to Indianapolis-Area Home and Business Owners 2
... (NYSE: HB ) today announced its fiscal 2008 ... declared by Hillenbrand,s,Board of Directors on February 7, 2008, ... record at the close of business on March 17, ... is organized into two operating companies,serving the health care ...
... 6 times more likely to make mistakes , , FRIDAY, ... are about six times more likely to make medication errors ... a 123 pediatric residents at three children,s hospitals in the ... residents were depressed, and 74 percent were burned out. During ...
... CJPS Enterprises, LLC, (http://www.cjps-enterprises.com ) announced that it ... and licensing of intellectual property (IP)., The ... already,making its website available to universities, research organizations, ... "You have,to fill the shelves of the store ...
... Oversee Phase 3 Program of CGT-2168, ... Pharmaceuticals,Inc., today named a distinguished international panel ... Steering Committee charged with overseeing COGENT,the company,s ... its novel,combination antiplatelet product CGT-2168., (Logo: ...
... Mylan Inc. (NYSE: MYL ),today announced that Mylan ... judge in Florida finding that the inclusion of,Levothyroxine Sodium ... of legislative authority and that the product should be ... products available to pharmacies in Florida as soon,as motions ...
... MBF Healthcare,Acquisition Corp. (AMEX: MBH ), a ... it will host an investor,conference call on Friday, ... to,discuss the recently announced signing of a definitive ... (along with its,subsidiaries, "CHS"). Hosting the call from ...
Cached Medicine News:Health News:Depression in Young Doctors Tied to Medication Errors 2Health News:CJPS Enterprises Spins Off New Company for Intellectual Property Marketing 2Health News:Cogentus Pharmaceuticals Names Scientific Steering Committee for Global Phase 3 Clinical Program 2Health News:Cogentus Pharmaceuticals Names Scientific Steering Committee for Global Phase 3 Clinical Program 3Health News:Mylan Restores Availability of Generic Levothyroxine in Florida 2Health News:MBF Healthcare Acquisition Corp. to Host Investor Conference Call to Review Stock Purchase Agreement Signed With Critical Homecare Solutions Holdings, Inc. 2Health News:MBF Healthcare Acquisition Corp. to Host Investor Conference Call to Review Stock Purchase Agreement Signed With Critical Homecare Solutions Holdings, Inc. 3Health News:MBF Healthcare Acquisition Corp. to Host Investor Conference Call to Review Stock Purchase Agreement Signed With Critical Homecare Solutions Holdings, Inc. 4
... of some micro vascular clamps can be ... use, Stainless steel changes its elasticity, causing ... pressures above 30g/mm2 may be associated with ... titanium which does not change its elasticity ...
... daylight into the surgical suite with the ... a variety of applications - including use ... - this light source delivers instant clean ... for superb tissue definition, even in hard-to-see ...
Designed for simple operation, the Model 515C pulse oximeter is ideal for use in any clinical setting; from emergency hospital transport to continuous monitoring in Anesthesia, Intensive Care and Gen...
... The Models 512 and 513 ... processing. This advanced technology is able ... higher resolutions and speeds of 100 ... results in improved pulse oximeter performance ...
Medicine Products: