FDA has expanded the approved use of oral anticoagulant rivaroxaban (Xarelto, Janssen) to include three new indications: treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), and reducing the risk of recurrent DVT and PE following initial treatment.
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.