Drug Index

ENBREL

Generic: ETANERCEPT

Review priority: STANDARD Marketing status: Prescription

Route: SUBCUTANEOUS
Class: General Medications
Safety profile: routine
Latest regulatory update: 30 Jan 2026, 12:00 am (UTC)

Structured Monograph

Approval overview ENBREL is listed in Drugs@FDA under application 103795 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETANERCEPT Form and strength VIAL; SUBCUTANEOUS - 25MG/VIAL Sponsor IMMUNEX Submission history Latest submission status date: 2026-01-30 00:00:00. Submission type: SUPPL.