Drug Index

FABRAZYME

Generic: AGALSIDASE BETA

Review priority: STANDARD Marketing status: Prescription

Route: INTRAVENOUS
Class: General Medications
Safety profile: routine
Latest regulatory update: 10 Jul 2024, 12:00 am (UTC)

Structured Monograph

Approval overview FABRAZYME is listed in Drugs@FDA under application 103979 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient AGALSIDASE BETA Form and strength VIAL; INTRAVENOUS - 35MG/VIAL Sponsor GENZYME Submission history Latest submission status date: 2024-07-10 00:00:00. Submission type: SUPPL.