FDA Approves New Fosamprenavir Dose Regimen, Nevirapine Tablets for HIV+ Children

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The U.S. Food and Drug Administration (FDA) has approved new dosing recommendations for use of fosamprenavir (Lexiva) oral suspension for children with HIV. The agency also approved a generic nevirapine tablet for use by HIV positive children in PEPFAR countries.

On April 27, 2012, the Food and Drug Administration approved dosing recommendations for use of fosamprenavir oral suspension for pediatric HIV patients. The update is based on data from 3 studies showing that ritonavir-boosted fosamprenavir as part of a combination antiretroviral regimen is safe and effective for children between the ages of 4 weeks and 6 years. Fosamprenavir/ritonavir should be taken twice-daily, with the dose calculated according to body weight.

The full FDA announcement is available online. The complete updated label information will be posted soon to Drugs@FDA, on the FDA web site.

The FDA this week also granted tentative approval for 50 mg and 100 mg nevirapine tablets for oral suspension, for use by HIV positive children weighing at least 5 kg. The new scored tablets, produced by Cipla Limited in India, will be available in countries that receive funding under the President's Emergency Plan for AIDS Relief (PEPFAR) program.

The full announcement is available online. A complete list of all approved and tentatively approved antiretrovirals for PEPFAR is available on the FDA web site.

5/2/12

Sources

R Klein and K Struble. New pediatric Lexiva dosing regimen for patients from at least 4 weeks to less than 6 years of age. FDA HIV/AIDS Update. April 29, 2012.

R Klein and K Struble. Tentative approval of nevirapine tablets for oral suspension, 50 mg and 100 mg for pediatric use. FDA HIV/AIDS Update. May 1, 2012.