Food and Drug Administration - November 25, 2009

On November 24, 2009, FDA approved revisions to the INTELENCE (etravirine) labeling to include updated results through 48 weeks of dosing for the two Phase 3 trials TMC125-C206 and TMC125-C216 in treatment-experienced patients. This constitutes the required confirmatory data for Traditional approval.

Food and Drug Administration - November 25, 2009

On November 24, 2009, the Food and Drug Administration granted tentative approval for generic efavirenz tablets, 50 mg, 100 mg, and 200 mg under expedited review procedures for the President s Emergency Plan for AIDS Relief (PEPFAR).

Food and Drug Administration - November 24, 2009

On November 20, 2009, the Food and Drug Administration approved a supplemental NDA to expand the indication for Selzenttry (maraviroc) to include combination antiretroviral treatment of therapy na?ve adults infected with CCR5-tropic HIV-1 virus.

Food and Drug Administration - November 24, 2009

On November 23, 2009, FDA approved changes to the Norvir package insert (product label) to include drug-drug interaction information for concurrent ritonavir administration with: *inhaled medicines such as salmeterol or salmeterol in combination with fluticasone propionate (Serevent, Advair)
* sildenafil (Revatio)

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