Tentative nod from USFDA for Ranbaxy's cancer drug valganciclovir

The US Food and Drug Administration has granted its tentative approval for Ranbaxy's valganciclovir hydrochloride tablets, in 450 mg dosage, a drug which had total annual market sales for of $239 million (IMS – MAT: March 2008).

Ranbaxy says that it 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, (a registered trademark of Roche).

 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 US healthcare system.