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:6/23/2016)... /PRNewswire/ - FACIT has announced the creation of ... company, Propellon Therapeutics Inc. ("Propellon" or "the Company"), ... portfolio of first-in-class WDR5 inhibitors for the treatment ... represent an exciting class of therapies, possessing the ... cancer patients. Substantial advances have been achieved with ...
(Date:6/23/2016)... 2016  The Biodesign Challenge (BDC), a university competition ... harness living systems and biotechnology, announced its winning teams ... New York City . The ... projects at MoMA,s Celeste Bartos Theater during the daylong ... senior curator of architecture and design, and Suzanne ...
(Date:6/23/2016)... Apellis Pharmaceuticals, Inc. today announced positive ... its complement C3 inhibitor, APL-2. The trials were ... studies designed to assess the safety, tolerability, pharmacokinetics ... healthy adult volunteers. Forty subjects were ... dose (ranging from 45 to 1,440mg) or repeated ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... on quality, regulatory and technical consulting, provides a free webinar on ... on July 13, 2016 at 12pm CT at no charge. , Incomplete investigations ...
Breaking Biology Technology:
(Date:3/31/2016)... 31, 2016  Genomics firm Nabsys has completed a ... Barrett Bready , M.D., who returned to the company ... technical leadership team, including Chief Technology Officer, John ... Steve Nurnberg and Vice President of Software and Informatics, ... Dr. Bready served as CEO of Nabsys ...
(Date:3/23/2016)... WAKEFIELD, Massachusetts , March 23, 2016 ... kombiniert im Interesse erhöhter Sicherheit Gesichts- und ... Xura, Inc. (NASDAQ: MESG ... heute bekannt, dass das Unternehmen mit SpeechPro ... insbesondere aus der Finanzdienstleistungsbranche, wird die Möglichkeit ...
(Date:3/22/2016)... , PROVO and ... -- Newborn Screening Ontario (NSO), which operates the highest ... for molecular testing, and Tute Genomics and UNIConnect, leaders ... technology respectively, today announced the launch of a project ... sequencing (NGS) testing panel. NSO has ...
Breaking Biology News(10 mins):