New protease inhibitor granted FDA approval

The Food and Drug Administration has approved a liquid formulation of the HIV-1 protease inhibitor Agenerase (amprenivar) by Vertex Pharmaceuticals/Glaxo Wellcome. The approval is aimed at expanding the use of the drug for pediatric patients by promoting easier administration of combination therapies.

The drug originally was approved in a solid form in April of this year. The new approval comes with recommended pediatric doses of 22.5 mg/kg twice daily or 17 mg/kg three times daily (for patients 4 to 12 years old or up to 16 if weighing less than 50 kg). The capsule and oral formulations are not interchangeable on a milligram-per-milligram basis.

The drug is available in grape, bubblegum, and peppermint flavors in 240 ml bottles (15 mg/ml) at a wholesale price of $25.20.

[For more information, contact Glaxo Wellcome at (919) 483-8580.]