Reuters
Mumbai: India’s Ranbaxy Laboratories Ltd has received tentative approval from the US Food and Drug Administration for the generic version of Roche’s anti-viral Valcyte, saying it believed it was the first to file.
Ranbaxy said it had tentative approval to make and market 450 mg tablets of valganciclovir hydrochloride, which prevents unnecessary cases of blindness.
The first-to-file status would give Ranbaxy a potential 180 days marketing exclusivity.