FDA Approvals - APP Pharma gets US FDA nod for additional dosages of
APP Pharma gets US FDA nod for additional dosages of Granisetron HCl injection (PharmaBiz)
APP Pharmaceuticals, Inc., a leading manufacturer of multi-source and branded injectable pharmaceutical products, has received final approvals from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Granisetron hydrochloride injection, 1 mg/mL, 1 mL single dose, and 1mg/mL, 4mL multiple dose vials, the generic equivalent of Hoffmann-LaRoche's Kytril ...
Epeius Biotechnologies' Tumor Targeted Rexin G Receives FDA Orphan Drug Designation For The Treatment Of Osteosarcoma (Medical News Today)
Epeius Biotechnologies Corporation announced that Rexin-G has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma.