Navigation Links
ISTA Pharmaceuticals' New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration
Date:1/15/2009

IRVINE, Calif., Jan. 15 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced that ISTA's New Drug Application (NDA) for Bepreve(TM) (bepotastine ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The Company is seeking approval for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The Company expects a standard review of ten months and has been given a user fee action date of September 12, 2009.

ISTA's Phase III clinical studies with Bepreve demonstrated highly statistically significant reductions in the primary endpoints of ocular itching. In addition, the results showed Bepreve had a statistically significant effect on the rapidity of response and on additional signs or symptoms of ocular allergy, including improvement in nasal symptoms. There were no serious ocular adverse events reported in patients dosed with Bepreve.

About Bepreve(TM) (bepotastine ophthalmic solution)

Assuming approval from the FDA, Bepreve would participate in ISTA's largest market to date. IMS Health estimates the U.S. ocular allergy market generated approximately $560 million in sales in 2007. Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells and it suppresses the migration of eosinophils into inflamed tissues. The compound's primary mechanisms of action are believed to make it an effective treatment against the signs and symptoms of allergic conjunctivitis.

Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the b
'/>"/>

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

Page: 1 2 3

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:8/22/2014)... , Aug. 22, 2014  Medical Science Liaisons serve ... leaders in the healthcare sector. As the impact of ... is changing how Medical Science Liaisons (MSLs) interact with ... are using the tablet to not only share important ... better coordinate thought leader interactions across geographies and therapeutic ...
(Date:8/22/2014)... , August 22, 2014 ... Markets ( http://www.researchandmarkets.com/research/x34qgv/global_laboratory ) has announced the addition ... 2014-2018"  report to their offering.  ... is an essential instrument for any modern ... precise weighing of materials. It can be ...
(Date:8/22/2014)... , August 22, 2014 ... has announced the addition of the  "Global ... their offering.       (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ... with a sterile environment in a healthcare ... is equipped with technically advanced equipment, which ...
Breaking Medicine Technology:iPads Enhancing Medical Science Liaison Interactions with Thought Leaders, New Study Shows 2Global Laboratory Electronic Balance Market 2014-2018: Key Vendors are A&D Company, Mettler-Toledo, Sartorius and Thermo Fisher 2Global Operating Room Equipment Market 2014-2018: Key Vendors are Getinge, STERIS, Stykron and TRUMPF Medical Systems 2
... Boston Scientific Corporation (NYSE: BSX ) announces ... be presented at Digestive Disease Week ® (DDW), ... involve the SpyGlass ® Direct Visualization System, WallFlex® ... Needle and Resolution® Clip. "The volume and ...
... Pharmaceuticals, Inc. (NYSE: WPI ) today ... an Abbreviated New Drug Application (ANDA) with the ... to market Norethindrone Acetate/Ethinyl Estradiol and Ethinyl Estradiol and ... 75 mg. Watson,s ANDA product is a generic ...
Cached Medicine Technology:Boston Scientific Endoscopy Presents Promising Clinical Data During Digestive Disease Week ® 2Boston Scientific Endoscopy Presents Promising Clinical Data During Digestive Disease Week ® 3Boston Scientific Endoscopy Presents Promising Clinical Data During Digestive Disease Week ® 4Boston Scientific Endoscopy Presents Promising Clinical Data During Digestive Disease Week ® 5Watson Confirms Lo Loestrin® Fe Patent Challenge 2Watson Confirms Lo Loestrin® Fe Patent Challenge 3
(Date:8/23/2014)... "Many men refuse to touch the toilet in ... in urine and spit," said an inventor from Decorah, ... came up with this hygienic device." , He developed ... the toilet seat before urinating. The unit ends the ... with dirt and germs. The accessory prevents urine from ...
(Date:8/23/2014)... The report “Polycarbonate Resin Market ... to 2018” defines and segments the global polycarbonate ... global revenue and consumption. It also identifies driving ... market with analysis of trends, opportunities, burning issues, ... and revenues are forecasted on the basis of ...
(Date:8/23/2014)... York (PRWEB) August 23, 2014 ... the 2012 GranuFlo and NaturaLyte dialysis concentrate recall ... underway in U.S. District Court, District of Massachusetts, ... docket report issued by the U.S. Judicial Panel ... least 2,028 claims are pending in the proceeding. ...
(Date:8/23/2014)... 23, 2014 Peripheral intervention surgeries are ... plaques, etc, thereby addressing the root cause of peripheral ... blood to the other part of the arteries where ... These procedures require the use of a catheter, (which ... polymers), these catheters are inserted through a thin cut ...
(Date:8/23/2014)... According to the new research report, "Electronic ... - Regional Trends & Forecast to 2019," defines ... analysis and forecast of value individually. Along with ... by applications and geography are also discussed in ... and 26 figures spread through 234 pages and ...
Breaking Medicine News(10 mins):Health News:Polycarbonate Resin Market by Applications and Geography Projected to $18.3 Billion by 2018 - New Report by MarketsandMarkets 2Health News:Polycarbonate Resin Market by Applications and Geography Projected to $18.3 Billion by 2018 - New Report by MarketsandMarkets 3Health News:Polycarbonate Resin Market by Applications and Geography Projected to $18.3 Billion by 2018 - New Report by MarketsandMarkets 4Health News:GranuFlo Lawsuits Mount in Federal Litigation, as Filings Surpass 2,000, Bernstein Liebhard LLP Reports 2Health News:GranuFlo Lawsuits Mount in Federal Litigation, as Filings Surpass 2,000, Bernstein Liebhard LLP Reports 3Health News:GranuFlo Lawsuits Mount in Federal Litigation, as Filings Surpass 2,000, Bernstein Liebhard LLP Reports 4Health News:Global Peripheral Intervention Market: Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Health News:Global Peripheral Intervention Market: Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3Health News:Global Peripheral Intervention Market: Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 4Health News:Electronic Adhesives Market Poised to Reach $5.5 Billion by 2019 - New Report by MarketsandMarkets 2Health News:Electronic Adhesives Market Poised to Reach $5.5 Billion by 2019 - New Report by MarketsandMarkets 3
... lutenizing hormone-releasing hormone agonist, reduces the long-term risk of ... breast cancer who did not take tamoxifen, according to ... of the Journal of the National Cancer Institute. ... hormone agonists, including goserelin, reduce the risk of disease ...
... to a cardiologist to go through a standard battery of ... coronary artery disease which is the most common cause of ... and these women are sent home with little more than ... similar symptoms and are more likely to develop future cardiac ...
... 24, 2009 Diagnosing acute stroke is a high-pressure ... all the difference. Early treatment can stop brain damage, ... increase the risk of bleeding in the brain. , ... stroke treatmenta clot-busting enzyme known as tissue plasminogen activator ...
... 23, 2009) Postpartum depression is a seriousand often ... mothers. Some of the causes might include personal history ... financial or emotional support. Left untreated, it can have ... on her child,s development. , In the ...
... Hanover Insurance Group, Inc. (NYSE: THG ... to the company,s board of directors at its ... principal of Taggart Associates in Cambridge, Mass., which ... work on corporate and non-profit boards.(Logo: http://www.newscom.com/cgi-bin/prnh/20051031/NEM023LOGO ...
... that can pose a big public health threat, researchers ... their release from Texas prisons, only 5 percent of ... treat their condition within the necessary 10 days, a ... therapy] at this time are at increased risk of ...
Cached Medicine News:Health News:Goserelin improves long-term survival in premenopausal women with early breast cancer 2Health News:Cardiologists initiate STILETTO study to investigate treatment options for women with chest pain 2Health News:Stroke treated significantly faster and just as safely by medical residents 2Health News:Stroke treated significantly faster and just as safely by medical residents 3Health News:Diabetes a risk factor for postpartum depression 2Health News:The Hanover Insurance Group Elects Harriett Tee Taggart to Board of Directors 2Health News:The Hanover Insurance Group Elects Harriett Tee Taggart to Board of Directors 3Health News:Most HIV-Infected Prisoners Go Untreated After Release 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: