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 Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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