
Intellectual Property - February 5, 2015
FDA, Veloxis Dispute Continues
The U.S. Food and Drug Administration (FDA) has informed Veloxis Pharmaceuticals A/S that the FDA still maintains that the exclusivity for Astagraf XL should require delays in the formal approval of Envarsus® XR. The FDA has stated that it would be prepared to approve Envarsus XR for use only in patients transitioned from an immediate […]