The FDA has approved Gvoke VialDx (glucagon) for IV use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the GI tract.
Bio-Thera Solutions, the developer of the biosimilar, will continue to hold manufacturing rights in the US market.
Vadodara: Alembic Pharmaceuticals Limited has announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application ...
Alembic Pharmaceuticals has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDAPantoprazole Sodium for Injection, 40 mg/vial ...