FDA nod to Tibotec’s PREZISTA for treating HIV-1 infection

The U.S. Food and Drug Administration has expanded the indication for Tibotec Pharmaceuticals’ PREZISTA (darunavir) tablets once-daily dosing as a part of the HIV combination therapy in adult patients who have not taken medication for HIV before. Also, PREZISTA has been approved as a twice-daily for use in adults with a prior experience of treatment. With this approval, the protease inhibitor when administered with 100 mg PREZISTA/r (ritonavir) and other ARVs (antiretroviral agents) can be used for the treatment of HIV-1 infection.

FDA approves Reyataz capsules for treating HIV-1 infection

Bristol-Myers Squibb Co.’s Reyataz (atazanavir) capsule (300 mg) has been approved by the U.S. Food and Drug Administration for use in combination with ritonavir (100 mg) to treat HIV-1 infection. On the basis of results of the year-long trial which show that atazanavir was as effective as lopinavir along with ritonavir in achieving virologic response  in adult patients who received tenofovir and emtricitabine (300 mg/200 mg once daily) therapy simultaneously.