FDA APPROVES BMS' 300-MG FORMULATION OF REYATAZ

Bristol-Myers Squibb (BMS) announced that the FDA has granted approval of a new 300-mg single-capsule formulation of Reyataz (atazanavir sulfate) for the treatment of HIV-1 infection in adults as part of combination therapy. Taken once daily along with ritonavir and food as part of a anti-HIV drug regimen, the Reyataz 300-mg formulation can replace two 150-mg capsules for patients who have previously received anti-HIV medicines, patients who will be receiving tenofovir disoproxil fumarate and patients who have never taken anti-HIV medicines that require Sustiva (efavirenz) as part of their anti-HIV drug regimen.

"With the Reyataz 300-mg single-capsule formulation approval, Bristol-Myers Squibb now has one pill, once-daily HIV medicine options available in three drug classes, as part of combination therapy," Anthony Hooper, the company's president, said.

Reyataz blocks the action of the HIV protease enzyme, which is needed for the virus to multiply. The drug has been studied in 48-week trials in patients who have taken or have never taken anti-HIV medicines. Since Reyataz was initially approved by the FDA in 2003, approximately 129,000 patients in the United States have been treated with the drug. The company will continue to produce the drug as 200-, 150- and 100-mg once-daily capsules.