FDA actions in brief
Hepatitis B immune globulin (HepaGam B, Cangene) was approved for the treatment of acute exposure to blood containing the hepatitis B surface antigen (HbsAg), perinatal exposure of infants born to mothers who are positive for HbsAg, sexual exposure to individuals who are HbsAg-positive, and household exposure to individuals with acute HBV infection.
Hepatitis B immune globulin (HepaGam B, Cangene) was approved for the treatment of acute exposure to blood containing the hepatitis B surface antigen (HbsAg), perinatal exposure of infants born to mothers who are positive for HbsAg, sexual exposure to individuals who are HbsAg-positive, and household exposure to individuals with acute HBV infection.
FDA approved rituximab (Rituxan, Genentech/ Biogen Idec) in combination with anthracycline-based chemotherapy regimens as a first-line treatment for diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma.
FDA approved desloratadine 2.5 mg/pseudoephedrine 120 mg (Clarinex-D 12 Hour, Schering-Plough) extended-release tablets as a treatment for nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in patients aged 12 years or older.
The selegiline transdermal system (Emsam, Bristol-Myers Squibb/Somerset) was approved for the treatment of major depressive disorder. It is the first transdermal patch to be approved for this indication.
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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