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's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.

* Valcyte(R) is a registered trademark of Roche

Chuck Caprariello

Vice President, Corporate Communications and Government Affairs

Ranbaxy Inc.

(609) 720-5615

Edwige Buteau

RF Binder

(212) 994-7517

Caroline Dickson

RF Binder

(212) 994-7560


'/>"/>
SOURCE Ranbaxy Laboratories Limited
Copyright©2008 PR Newswire.
All rights reserved

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:1/12/2017)... , January 12, 2017 ... the world,s biggest facility for producing mycorrhizae. The Centre ... nutrient tapping potential of mycorrhizae and developed a technology ... ... http://mma.prnewswire.com/media/456932/PRNE_TERI_Logo.jpg) The TERI facility has ...
(Date:1/12/2017)... , January 12, 2017 The report "Direct-Fed Microbials Market by Type ... (Dry and Liquid), and Region - Global Forecast to 2022", published by MarketsandMarkets, ... 2016 and projected to reach USD 1,399.6 Million by 2022, at a CAGR ... ... MarketsandMarkets Logo ...
(Date:1/11/2017)... , ... January 11, 2017 , ... ... fertility specialists with accurate and reliable preimplantation genetic screening (PGS). , “Our genetics ... excellent results,” says Ovation Fertility Genetics Scientific Director Amy Jones, M.S., ELD ...
(Date:1/11/2017)... Jan. 11, 2017  Brian Mehling, M.D., world-renowned stem ... Blue Horizon International (BHI), will be attending the 47th ... from January 17-20, 2017. This will be ... The theme of this year,s forum is Responsive ... sessions will address strategies for fostering greater social inclusion ...
Breaking Biology Technology:
(Date:1/6/2017)... Colo. , Jan. 5, 2017  SomaLogic ... the "Digital Life Alliance" established by iCarbonX, the ... 2015 to build a "Global Digital Health Ecosystem ... on a combination of individual,s biological, behavioral and ... the agreement between the companies, SomaLogic will provide ...
(Date:1/4/2017)... , Jan. 4, 2017  For the thousands of attendees at this ... leader in connected health and biometric measurement devices and services, will be ... On display in A&D Medical,s special CES Exhibit Suite , ... ongoing expansion of the company,s WellnessConnected product platform.  ... ...
(Date:1/3/2017)... LAS VEGAS , Jan. 3, 2017 ... announced the introduction of Onitor Track, an innovative biometric ... and men, showcasing this month at the 2017 Consumer ... . In the U.S., the World ... affect more than two-thirds of adults who are overweight ...
Breaking Biology News(10 mins):