Octapharma USA’s NUWIQ Receives FDA Approval for Expanded Vial Strengths

The U.S. Food and Drug Administration has approved new product strengths for Octapharma’s NUWIQ, offering added convenience by potentially reducing the number of vials needed for hemophilia A patients. Approval is for new single-dose vial strengths of 2,500, 3,000 and 4,000 international units (IUs), which became available in the U.S. in September. These are in addition to the already available 250, 500, 1,000 and 2,000 IUs. NUWIQ is the only recombinant factor VIII providing patients a wide array of vials with the lowest diluent volume of 2.5 ml. “The new vial options will benefit patients, physicians and healthcare professionals by providing greater treatment flexibility and convenience,” said Octapharma USA President Flemming Nielsen. “The variety of vial options will be particularly beneficial to patients who previously may have needed more than one of the lower-strength vials.”