Navigation Links
Ranbaxy Gains Tentative Approval to Manufacture and Market Valganciclovir Hydrochloride Tablets
Date:6/25/2008

'First-to-File' Status Will Provide 180-Day Marketing Exclusivity Upon

Final Approval

PRINCETON, N.J., June 25 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL), announced today that the company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. Total annual market sales for Valganciclovir HCl Tablets were $239 million (IMS - MAT: March 2008).

Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future.

Valganciclovir HCl Tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir HCl is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [(D+/R-)]).

"Ranbaxy is pleased to receive this tentative approval for Valganciclovir Hydrochloride Tablets, a medicine that has established its clinical value and utility over time. It will be launched by Ranbaxy upon receiving final approval and resolution of litigation currently pending in Federal District Court, as an affordably priced alternative to the branded product, Valcyte. This product formulation will further expand our portfolio of affordable generic alternatives and will be available to all classes of trade," said Bill Winter, Vice President of Trade Sales for RPI, USA. "This represents another potentially strong market entry for Ranbaxy medicines from among our pipeline of patent challenges, and offers us a significant future opportunity," Winter added.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India
'/>"/>

SOURCE Ranbaxy Laboratories Limited
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Ranbaxy to Consolidate Position in Biopharmaceuticals and Speciality Injectables Including Oncology
2. Astellas and Boehringer Ingelheim Reach Settlement Agreement with Ranbaxy on Flomax Patent Case
3. Ranbaxy Receives Tentative Approval to Manufacture and Market Esomeprazole Magnesium DR Capsules
4. Ranbaxy and AstraZeneca Reach Agreement in Esomeprazole Patent Litigation
5. Shareholder Class Action Filed Against GPC Biotech AG by the Law Firm of Schiffrin Barroway Topaz & Kessler, LLP
6. FDA Approves ACAM2000(TM) Vaccine for Protection Against Smallpox
7. Former Banc of America Securities Analyst David Maris Comments on Decision by Biovail to Drop Its Claims Against Him; Denies That He is Cooperating With Biovail
8. Sangamo BioSciences Presents Data Demonstrating In Vivo Protection Against HIV Infection by CCR5-ZFN Therapeutic
9. Shareholder Class Action Filed Against LCA-Vision, Inc. by the Law Firm of Schiffrin Barroway Topaz & Kessler, LLP
10. N-Viro International Corporation Announces Dismissal of Lawsuit Against It
11. Hospitals Adopt STERIS Advanced Room Sterilization Technology in the Fight Against Superbugs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/1/2015)... TRIANGLE PARK, N.C. , May 1, 2015  United ... Roger Jeffs , Ph.D., President and Co-Chief Executive Officer of ... company,s business at the Deutsche Bank 40 th Annual ... The presentation will take place on Wednesday, May ... accessed via a live webcast on the United Therapeutics website ...
(Date:4/30/2015)... SAN DIEGO , April 30, 2015   ... drugs, announced today an update on its Ebola antiviral ... of Tamir,s leading candidates, TMR004, is currently being evaluated ... frontline of the battle against Ebola. During the first ... Voice And Leadership Meeting To Accelerate The Evaluation of ...
(Date:4/30/2015)... Nitto Avecia, a leading biotechnology ... capacity and production capability to serve biotechnology pharmaceutical ... service fulfillment continues to drive Nitto Avecia to ... capacities. , In Fall 2014, Nitto ... equipment at its Milford, MA facility, which is ...
(Date:4/30/2015)... (PRWEB) April 30, 2015 Biodata, ... notebook with integrated protocols and specimen management systems, ... solutions and consulting services for life science research, ... of Labguru’s newest feature: chemical structure and reaction ... features for biologists, bio-chemists, and more, the integration ...
Breaking Biology Technology:Tamir Biotechnology Provides Update on TMR004 Development Against Mutating Ebola 2Tamir Biotechnology Provides Update on TMR004 Development Against Mutating Ebola 3Tamir Biotechnology Provides Update on TMR004 Development Against Mutating Ebola 4Biotechnology Manufacturer Nitto Avecia Expands Capacity to Meet Client Demand 2Labguru Integrates ChemAxon's Marvin JS, to Enhance Functionality for Chemists 2
... to the devastation across Greece caused by this summers ... of crisis map products based on satellite acquisitions of ... efforts following the activation of the International Charter on ... were killed and thousands left homeless in the worst ...
... - Dr. Jean-Luc Girardet Promoted to Vice President, ... O,Connor to Establish a New Non-Profit Foundation, ... Pink Sheets: ARDC), a company focused on the ... of viral,diseases, cancer and inflammatory diseases, today announced ...
... Synvista Therapeutics,Inc. (AMEX: SYI ) announced ... Executive Officer will be featured in an exclusive,interview ... 11:00 a.m. EDT. Dr. Berkowitz will discuss ... ALT-2074 in cardiovascular diseases, and alagebrium in,heart failure ...
Cached Biology Technology:Greeks get space-based help in wake of deadly fires 2Ardea Biosciences Announces Changes to Research Management 2Ardea Biosciences Announces Changes to Research Management 3Synvista Therapeutics to be Featured on Wallst.net 2
(Date:4/13/2015)... April 13, 2015 According ... "Global Biometrics Market Forecast & Opportunities, 2020", the global ... of around 14% till 2020. The biometrics market ... scale implementation and review of biometric management systems. ... new products with greater efficiency, are resulting in ...
(Date:4/8/2015)... 2015  Infinisource, a leading provider of SaaS-based Human ... a leading supplier of biometric identification and security ... most advanced biometrically-enabled time clock, the companies announced ... is setting a bold, new standard for the ... small and mid-size employer. When connected to the ...
(Date:4/2/2015)... Sweden , April 2, 2015 ... for Q1 2015 attributed to somewhat higher than 125 ... in the year-end report 2014 that revenues for Q1 ... that the company reported for Q4 2014. The operating ... to be negative. The complete interim report will as ...
Breaking Biology News(10 mins):Global Biometrics Market to Cross US$ 21 Billion by 2020: TechSci Research 2iSolved Time Clock Offers Unmatched Accuracy due to Morpho Biometrics 2iSolved Time Clock Offers Unmatched Accuracy due to Morpho Biometrics 3Fingerprint Cards Revises Revenues for Q1 2015 2
... academy of sciences for the developing world, will hold its ... Africa, on 20-23 October 2009. The conference is being hosted ... and supported by South Africa,s Department of Science and Technology. ... of symposia, ranging from an in-depth look at the state ...
... of air pollution, or smog, is a highly reactive, ... Although ozone pollution is most often associated with outdoor ... and offices. Ozone can be released by ordinary copy ... purification systems, all of which contribute to increased indoor ...
... CITY) In a finding with potentially major implications ... at the University of Utah and Columbia University medical ... to cause leukemia and sarcomas in animals has been ... cancer cells. If further investigation proves the ...
Cached Biology News:Houseplants cut indoor ozone 2Researchers find first evidence of virus in malignant prostate cells 2Researchers find first evidence of virus in malignant prostate cells 3
... specifically designed as a high tech shaker ... mass compensation allows high shaking speed even ... and, therefore, faster growth and higher cell ... when high reproducibility is critical ...
... cocktail of 3 siRNAs specifically targeted to ... popular product. The siTrio reagent guarantees you ... target gene when used under standard conditions ... of optimal transfection with one of B-Bridges ...
... iCycler thermal cycler with 96 x 0.2 ... acid amplification (PCR) applications. It is equipped ... microliter samples) that is compatible with optical ... monitoring and control by algorithm, block, or ...
... MULTI-FUN Incubator is a compact benchtop ... a microprocessor controller with a large ... and agitation speed. Air circulation inside ... incubator. Temperature can be easily calibrated ...
Biology Products: