FDA actions in brief, August 2009 (Ozurdex, Cambia, Ilaris, Feraheme, Plan B One-Step, Alimta, Isentress)
Recent FDA approvals (through August 2009) related to Ozurdex, Cambia, Ilaris, Feraheme, Plan B One-Step, Alimta, and Isentress
Dexamethasone intravitreal implant (Ozurdex, Allergan) was approved for the treatment of macular edema after branch retinal vein occlusion or central retinal vein occlusion.
An oral solution of diclofenac (Cambia, Kowa) was approved for the treatment of acute migraine with or without aura in adults.
Canakinumab (Ilaris, Novartis) was approved for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS).
A single-dose formulation of levonorgestrel 1.5 mg (Plan B One-Step, Teva) was approved on a prescription basis for the prevention of unintended pregnancy after unprotected sex or contraceptive failure in women aged <17 years.
Pemetrexed for injection (Alimta, Lilly) was approved as a maintenance therapy for the treatment of locally advanced or metastatic non-small cell lung cancer, specifically for patients with a nonsquamous histology whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy.
Raltegravir (Isentress, Merck) was approved for use in combination with other antiretrovirals for the treatment of HIV-1 infection in treatment-naïve adult patients.
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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