Ranbaxy granted FDA approval for generic Valcyte

PRINCETON, N.J. The Food and Drug Administration has granted Ranbaxy Laboraties tentative approval to manufacture and market valganciglovir hydrochloride in 450 mg tablets.

Ranbaxy may get 180-day marketing exclusivity due to possible first-to-file status on the tablets, which treat cytomegalovirus in patients with AIDS and prevent it in high-risk patients who have received kidney, heart and kidney-pancreas transplants.

The tablets are a generic version of Roche’s Valcyte, which had sales of $523.3 million in 2007, according to Roche financial data.