FDA: New Oral Powder Formulation Approved for HIV Treatment

The Food and Drug Administration (FDA) has approved a new oral powder formulation for Norvir (ritonavir, AbbVie).

Norvir, an HIV protease inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adults. The new formulation contains 100mg of ritonavir per packet.

The approval allows Norvir oral powder (only for >100mg dose increments) to be used with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection. It should not be used for doses <100mg or incremental doses between 100mg intervals; the oral solution is the preferred formulation for patients who need doses <100mg or incremental doses between 100mg intervals. 

The oral powder can be mixed over soft food or liquid and should be consumed within 2 hours of preparation. It can also be administered via a feeding tube after being mixed with water. 

Norvir is already available as 100mg tablets and softgel capsules as well as an 80mg/mL oral solution. Norvir oral powder packets are alcohol- and propylene glycol-free and are supplied in 30-count cartons.

For more information call (800) 633-9110 or visit Norvir.com.

References

NORVIR® [package insert]. North Chicago, IL: AbbVie Inc.; June 2017.

This article originally appeared on MPR