Subcutaneous IVIG now available
ZLB Behring has received FDA approval for the first subcutaneous immunoglobulin, Vivaglobin (Immune Globulin Subcutaneous [Human]), indicated for the treatment of patients with primary immunodeficiency. According to the company, patients can safely self-administer the immunoglobulin and the drug may be appropriate for those who cannot tolerate the intravenous products due to poor venous access or side effects. Portable pumps can be used by the patient to deliver their weekly doses.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
