FDA actions in brief
FDA approved the etonogestrel 68-mg implant (Implanon, Organon), a single-rod implantable device that prevents pregnancy for up to 3 years.
FDA approved the etonogestrel 68-mg implant (Implanon, Organon), a single-rod implantable device that prevents pregnancy for up to 3 years.
FDA approved rivastigmine (Exelon, Novartis) as the first treatment for mild-to-moderate dementia associated with Parkinson disease.
Bevacizumab (Avastin, Genentech) was approved in combination with intravenous 5-fluorouracil (5-FU)-based chemotherapy for the treatment of second-line metastatic colorectal cancer. The agent had been previously approved for first-line treatment of metastatic colorectal cancer in combination with IV 5-FU-based chemotherapy.
A topical anesthetic peel, packaged as a lidocaine 7%/tetracaine 7% cream formulation (Zars Pharma), was approved to be used prior to various superficial dermatologic procedures.
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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