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 Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
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FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
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FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
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