FDA actions in brief, May 2009 (Coartem, Ixiaro, Lexapro, Reclast, Symbyax)
Recent FDA approvals (through May 2009) related to Coartem, Ixiaro, Lexapro, Reclast, and Symbyax
Artemether 20 mg/lumefantrine 120 mg (Coartem, Novartis) was approved for the treatment of acute uncomplicated infections due to Plasmodium falciparum.
A vaccine (Ixiaro, Intercell) was approved for active immunization against viral infections of Japanese encephalitis.
Escitalopram (Lexapro, Forest) was approved for the acute and maintenance treatment of major depressive disorder in adolescent patients aged 12 to 17 years.
The combination of olanzapine and fluoxetine (Symbyax, Lilly) was approved for the acute treatment of treatment-resistant depression. Olanzapine (Zyprexa, Lilly) and fluoxetine (Prozac, Lilly) were also approved for use in combination for the acute treatment of treatment-resistant depression and for the acute treatment of bipolar depression.
Benzyl alcohol lotion, 5% concentration (Sciele) was approved for the treatment of head lice infestation in patients aged ≥6 months.
FDA Approves Subcutaneous Tecentriq to Treat Multiple Cancers
September 13th 2024Tecentriq Hybreza can be administered over seven minutes, compared with 30 to 60 minutes for IV infusion of Tecentriq. There is no word yet on when Tecentriq Hybreza will be available or what the price will be.
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FDA Warns of Liver Injury with Veozah for Hot Flashes
September 12th 2024The FDA has identified a probable case of serious drug induced liver injury that occurred in a woman in the United States who had received Veozah. The agency is requiring additional liver blood testing after starting therapy.
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