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.
Capricor Completes BLA for Deramiocel for Duchenne Cardiomyopathy
January 3rd 2025Deramiocel is a cell therapy that has healing effects in muscle cells. If approved, deramiocel would be a once-quarterly therapy and the first specifically approved for cardiomyopathy in patients with Duchenne muscular dystrophy.
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