FDA Approves Octaplas
Octapharma USA’s Octaplas, a solvent/detergent-treated pooled human plasma, has been approved by the U.S. Food and Drug Administration.
FDA Approves First Injectable Quadrivalent Flu Vaccine
The U.S. Food and Drug Administration has approved Fluarix Quadrivalent to immunize children ages 3 and older and adults against flu virus subtypes A and B.
Baxter Receives FDA Approval for Advate 4000 IU
Baxter International has received U.S. Food and Drug Administration approval for a 4,000 IU dosage of Advate (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free Method).
CSL’s rVlla-FP Granted Orphan Drug Designation
CSL Behring has been granted orphan drug designation by the U.S.Food and Drug Administration for its novel recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP).
FDA Approves Advate to Treat Hemophilia A
The U.S. Food and Drug Administration approved Baxter International Inc.’s Advate (antihemophilic factor [recombinant] plasma/albumin free method) for hemophilia A.
FDA Approves Pneumococcal Vaccine for Adults 50-Plus
The U.S. Food and Drug Administration has approved Pfizer’s Prevnar 13 for use in adults 50 years and older.
FDA Approves Supplemental Test for Chagas Disease
An additional, more specific test on human serum or plasma specimens found to be positive for antibodies to Trypanosoma cruzi (T. cruzi) has been approved by the U.S. Food and Drug Administration.
FDA Approves First Quadrivalent Flu Vaccine
The U.S. Food and Drug Administration has approved the first vaccine that protects against four strains of the common flu.
FDA Approves Rituxan for Two Rare Disorders
The U.S.Food and Drug Administration has approved Rituxan in combination with glucocorticoids to treat patients withWegener’s granulomatosis and microscopic polyangiitis.
Baxter Receives FDA Approval for Gammagard Liquid
The U.S.Food and Drug Administration has approved subcutaneous Gammagard Liquid 10% for patients with primary immunodeficiency.