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

0

GOOD

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:11/25/2009)... , , DURHAM, N.C., Nov. 25 /PRNewsw...nveiled the first energy-efficient, single-treatme...d from carbon nanotubes to Andhra Pradesh, Ministe...d other leaders in Hyderabad, India today. Initial...y (IIT) Kanpur, confirmed that the majority of the...
(Date:11/25/2009)... , , MARKHAM, ON, Nov. 25 /PRNewswire/ - ...r Moldt, PhD to its Board of Directors. Dr. Moldt ...sentative on the Company,s Board. The number of Bo..., "We are very pleased to welcome Peter Moldt to t...xperience and guidance as Cytochroma continues to ...
(Date:11/24/2009)... , This release is available in German . ,...ication cards: RFID tags (Radio Frequency Identifi...eryday life. They make it possible to label object...o frequency. The appropriate scanner can read and ...els can be affixed to goods under production condi...
(Date:11/24/2009)... , , SANTA CRUZ, Calif., Nov. 24 /PRN... joined Bio Career Center, the nation,s leading on...rofessionals. ,, Northwestern and Columbia Univ...8 other major life science training Institutions. ... only for post-graduates in the life sciences. Whi...
Breaking Biology Technology:North Carolina-based Cnanoz Unveils NanoPure(TM) to Government Leaders in Hyderabad, India 2Cytochroma Announces Appointment of Peter Moldt to Board of Directors 2Intelligence inside metal components 2Two Major Universities Join Nation's Leading Postgrad Bio Job Board 2
...nday highlighting university-business partnerships... a medical imaging company based in Hartland, Wis....ovascular health to John Dudas, acting under secre...k Office and U.S. Rep. F. James Sensenbrenner, R-...lso met with companies in Madison and discussed th...
...epreneur Ken Schlager started a company, he looked...his time around, Schlager is turning to the Center... as he launches a cutting-edge technology that app...t. , ,Schlager, a 75-year-old electrical engineer,...and removes organic materials, while also disinfec...
...es Inc. and Innogenetics NV announced Tuesday a...nder the terms of the agreement, Third Wave has gr...opean marketing and distribution rights for select... Third Waves first effort to penetrate the growing...agreement, Innogenetics European-wide sales organi...
Other Biology Technology:Sensenbrenner and USPTO Director highlight benefits of technology transfer 2Sensenbrenner and USPTO Director highlight benefits of technology transfer 3CTT - Bridging the states entrepreneurial gap 2CTT - Bridging the states entrepreneurial gap 3Third Wave lands European distribution deal, reports high earnings 2
(Date:11/26/2009)...s Aureus ) and other drug-resistant bacteria could...type devices have been developed to offer safe, qu... Two prototype devices have been developed: one f...nds and feet) in hospitals and public spaces where... shoot bacteria-killing agents into infested chron...
(Date:11/25/2009)...s. In addition to mammalian immune systems that be...acteriophages, viruses that kill half the bacteria... another class of microorganisms called archaea (f...ep-sea volcanic vents) manage just fine, thank you...tem that helps protect them from many viruses and ...
(Date:11/25/2009)...e linchpin of the environment, where atmosphere, b... students see soil as "just dirt" a place to grow...are challenged with the task of helping students a... soil in the environment. , A collaborative pro... University of Nebraska-Lincoln, Oregon State Univ...
Breaking Biology News(10 mins):Plasma produces KO cocktail for MRSA 2Plasma produces KO cocktail for MRSA 3Researchers discover biological basis of 'bacterial immune system' 2Researchers discover biological basis of 'bacterial immune system' 3It's not just dirt! 2Charles F Day and Associates LLC Sponsors Pandemic Flu Modeling Demonstration 59179 1Charles F Day and Associates LLC Sponsors Pandemic Flu Modeling Demonstration 59179 2National Nutrient Database Updated to Include Vitamin D Values 59177 1National Nutrient Database Updated to Include Vitamin D Values 59177 2National Nutrient Database Updated to Include Vitamin D Values 59177 3National Nutrient Database Updated to Include Vitamin D Values 59177 4Preventing Fungal Infections in HSCT Recipients 3A Insights from Clinical Cases 59175 1Preventing Fungal Infections in HSCT Recipients 3A Insights from Clinical Cases 59175 2
...sts from around the world will convene at the Univ... key findings from the most ambitious effort ever ...tants in the Arctic and determine how they contrib...way in the vast, climate-sensitive region. , The ...ARCAT was conducted most intensively during two th...
...ands, May 26, 2009 There are several risk factors...scular dementia. Based on an increasing number of ...deficiency, an article in the current issue of the...lliam B. Grant, PhD of the Sunlight, Nutrition, an...rther investigation of possible direct or indirect...
...sen sharply in developed countries in the wake of ...Europeans live with the condition. Foot problems a...for diabetics, who are at risk of serious complica...lood supply to their feet. Both conditions can lea... they get infected and become gangrenous, can lead...
Other Biology News:Spring agricultural fires have large impact on melting Arctic 2Spring agricultural fires have large impact on melting Arctic 3Is vitamin D deficiency linked to Alzheimer's disease and vascular dementia? 2Protective footwear for diabetics at a high-street price 2Protective footwear for diabetics at a high-street price 3
...L) can provide you with the expertise developed ov...ent and validation ,Performance of methods used ...g environment ,Assurance of quality for manufact...microbiological services to the pharmaceutical ind...
...ide whose sequence is from rat SCAMP 5. The seque...: C - N(217) - Q - P - Q - T - Q - Y - S - A - T ...ay be used for neutralization and control experime...this product and the rat SCAMP 5, catalog # PA1-73...
..., After we receive your antigen (see How to Prep...mber of chickens and begin to collect pre-immune e... a period of 3-5 days), we begin the injection ser... the breast muscle. The first is in Complete Freun...
... exists? Having difficulty generating antibodies i...of pharmaceutical, biotech and academic researcher...expertise in antibody generation to work for you. ...nology , High affinity and high specificity , High...
Biology Products: