New strength of Intelence gets regulatory approval
TITUSVILLE, N.J. — The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.
Tibotec Therapeutics, a subsidiary of J&J, said the FDA approved a 200-mg formulation of Intelence (etravirine) for treating HIV in patients who have taken previous treatments and whose virus has become resistant to antiretroviral drugs.
The recommended dosage of the drug is either 200 mg or two 100-mg tablets; the 100-mg tablets will remain available on the market, Tibotec said. The company expected to launch the 200-mg formulation later this month.