Gilead Sciences Inc., with drug operations in Branford, has refiled a new drug application with the FDA for its HIV combination drug, The Silicon Valley/San Jose Business Journal reports.
Gilead, based in Foster City, Calif., said the drug combines its Truvada with an investigational drug from Tibotec Pharmaceuticals, a unit of Johnson & Johnson.
The FDA has up to 60 days to perform a review of the drug, which was turned down last month because more information was needed. At the time the FDA said Gilead’s application did not contain enough information on some cited methodology.
Gilead’s Truvada alone brought in $682 million in sales last year.
