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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 Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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