Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall—High Out of Specification Impurity Results. AUDIENCE: Pharmacy, Risk Manager ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed in…
FDA Improves Access to Reports of Adverse Drug Reactions
FDA Approves New Treatment for Adults with Relapsed Follicular Lymphoma
FDA Approves First Biosimilar for the Treatment of Cancer
The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. “Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high,…
Federal Judge Enters Consent Decree Against Isomeric Pharmacy Solutions
Vyxeos Liposome for Injection Okayed for Patients with Two Types of AML
FDA Approves Treatment for Chronic Graft Versus Host Disease
FDA Approves New Treatment for Sickle Cell Disease
The U.S. Food and Drug Administration Friday approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. “Endari is the first treatment approved for patients with sickle cell disease in almost 20 years,” said Richard Pazdur, M.D., acting director of…