FDA actions in brief
Naltrexone extended-release injectable suspension (Vivitrol, Alkermes/Cephalon) was approved for the treatment of alcohol dependence in patients who can abstain from drinking in an outpatient setting and who are not actively drinking at the time treatment is initiated.
Naltrexone extended-release injectable suspension (Vivitrol, Alkermes/Cephalon) was approved for the treatment of alcohol dependence in patients who can abstain from drinking in an outpatient setting and who are not actively drinking at the time treatment is initiated.
FDA approved zanamivir inhalation powder (Relenza, GlaxoSmithKline) for the prevention of influenza A and B infection in patients aged 5 years or older. The antiviral treatment was previously approved to treat influenza A and B virus infections in adults and children.
Docetaxel injection concentrate (Taxotere, Sanofi-Aventis) was approved in combination with cisplatin and 5-fluorouracil for the treatment of advanced stomach cancer, including cancer of the gastroesophageal junction, in patients who have not previously received chemotherapy for advanced disease.
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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