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 Issues Complete Response for High-Dose Opioid Rescue Med
July 16th 2024OX124 is a nasal spray provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA would like to see additional technical data, as well as data on whether patients can correctly use the device.
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