Drug firm Ranbaxy Laboratories [Get Quote] said on Wednesday it has received tentative approval from the US Food and Drug Administration to manufacture and market Valganciclovir Hydrochloride 450 mg tablets, used in the treatment of prevention of blindness in AIDS patients.
The company has got the approval for the generic version of Roche's anti-viral 'Valcyte', which has a total annual market of around $239 million.
Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby, providing a potential of 180-days of marketing exclusivity which offers a significant opportunity in the future, the company said.
"This product formulation will further expand our portfolio of affordable generic alternatives and will be available to all segments of the society," Ranbaxy Pharmaceuticals Inc's Vice President Bill Winter said.
Ranbaxy Pharmaceuticals Inc is a wholly-owned subsidiary of Ranbaxy Laboratories and is based in Florida USA.
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