RANBAXY GAINS TENTATIVE APPROVAL TO MANUFACTURE
AND MARKET VALGANCICLOVIR HYDROCHLORIDE TABLETS
“First-to-File” Status Will Provide
180-Day Marketing Exclusivity Upon Final Approval
Princeton, New Jersey - June
25, 2008 -- 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® is a registered trademark of Roche
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