Norvir (ritonavir) oral powder, 100 mg packet

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Norvir (ritonavir) oral powder, 100 mg packet

Information about FDA HIV product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.

On June 7, 2017, the Food and Drug Administration approved a new Norvir (ritonavir) oral powder formulation, 100 mg packet. This approval provides for the use of Norvir (ritonavir) oral powder (only for >100 mg dose increments) in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection. Norvir oral powder dosage form is free of alcohol and propylene glycol, both of which are present in the currently marketed Norvir oral solution, making it safer for use in the pediatric population. 

Additionally, labeling was revised for the Norvir tablet for oral use and oral solution to reflect the new powder formulation.

 The complete revised labeling will be available soon at Drugs@FDA and at DailyMed.

 Norvir is manufactured by AbbVie Inc.

 

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Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the HIV Liaison Program visit the FDA Patient Network

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