FDA Updates Articles
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 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).
The U.S. Food and Drug Administration approved Baxter International Inc.’s Advate (antihemophilic factor [recombinant] plasma/albumin free method) for hemophilia A.
The U.S. Food and Drug Administration has approved Pfizer’s Prevnar 13 for use in adults 50 years and older.
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.
The U.S. Food and Drug Administration has approved the first vaccine that protects against four strains of the common flu.
The U.S.Food and Drug Administration has approved Rituxan in combination with glucocorticoids to treat patients withWegener’s granulomatosis and microscopic polyangiitis.
The U.S.Food and Drug Administration has approved subcutaneous Gammagard Liquid 10% for patients with primary immunodeficiency.
The U.S. Food and Drug Administration has approved Kedrion Biopharma’s Gammaked for the U.S.market.
Menactra, a vaccine for the prevention of invasive meningococcal disease for children ages 9 months and older, has been approved by the U.S. Food and Drug Administration.
Zostavax, the vaccine manufactured by Merck & Co. to prevent shingles, has been approved by the U.S. Food and Drug Administration for adults ages 50 to 59 years old.
The U.S. Food and Drug Administration has approved a single-use rapid test that detects antibodies to HIV-1 in as little as 60 seconds.