FDA Finalizes Guidance Documents on Biosimilars
The U.S. Food and Drug Administration(FDA) has finalized three guidance documents outlining its expectations for biosimilars.
FDA Accepts BLA for CSL’s rIX-FP for Hemophilia B Patients
CSL Behring’s Biologics LicenseApplication for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP) has been accepted for review by the U.S.
Second Octapharma Octagam 10% Manufacturing Site Approved by FDA
The U.S. Food and Drug Administration(FDA) has approved Octapharma’s manufacturing facility in Vienna, Austria, for the production of Octagam 10% (immune globulin intravenous [human] 10% [100mg/mL] liquid preparation).
FDA Approves Tivorbex
FDA has approved Iroko Pharmaceuticals’ Tivorbex (indomethacin), a low-dose painkiller for adult patients.
FDA Approves Obinutuzumab for CLL
The U.S. Food and DrugAdministration has approved obinutuzumab (Gazyva, Genentech)for the treatment of patients with previously untreated chronic lymphocyticleukemia.
FDA Approves Two New Quadrivalent Vaccines
The U.S. Food and Drug Administration has approved two new quadrivalent influenza vaccines (IIV4s).
FDA Orders New Boxed Warning for Hydroxyethyl Starch
The U.S. Food and Drug Administration (FDA) has determined that hydroxyethyl starch (HES) solutions should not be used in critically ill adult patients, including patients with sepsis and those admitted to the intensive care unit (ICU).
FDA Grants Expanded Indication Approval for CSL Behring’s Corifact
The U.S. Food and Drug Administration(FDA) has approved an expanded indication for CSL Behring’s Corifact, factor XIII (FXIII) concentrate (human) to include the perioperative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency.
FDA Approves VARIZIG for Treatment of Varicella Zoster Virus in High-Risk Patients
VARIZIG, a hyperimmune globulin indicated for post-exposure prophylaxis of varicella zoster virus (VZV) in high-risk patients, has been approved by the U.S.Food and Drug Administration.
FDA Approves Meningitis Vaccine for Children
The U.S. Food and Drug Administration has approved a new children’s vaccine that targets two common causes of bacterial meningitis.