Tibotec Seeks Traditional Approval for Intelence

After receiving accelerated approval last year for Intelence, a combination HIV therapy, Tibotec has followed up with an application for traditional approval, which would remove some of the restrictions on marketing the drug. The application for traditional approval includes data from two studies. If the studies do not show clinical benefit, the FDA has regulatory procedures that could lead to the drug’s removal from the market.
Washington Drug Letter