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.
ICER Finds Insurers Struggled to Provide Fair Access for Obesity Drugs
December 19th 2024The Institute for Clinical and Economic Review assessed the formularies of 11 payers, covering 57 million people, to determine access for drugs that the organization had reviewed in 2022 for cost-effectiveness.
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