FDA New Drug and Biologic Approvals, 2018 Midyear Review

New Indications

HIV-1: Truvada (emtricitabine/tenofovir DF)

Indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 expanded to include at-risk adolescents weighing at least 35 kg.

Hospital-Acquired/Ventilator-Associated Bacterial Pneumonia: Avycaz (ceftazidime/avibactam)

New indications for adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.