REBIFinterferon beta-1a

FDA approved the original biologics license application for REBIF on March 7, 2002, sponsored by SERONO INC. FDA classed that submission a new molecular entity, which makes it the first approval of interferon beta-1a in any product. FDA has approved 4 efficacy supplements on the application since, the most recent on May 26, 2020.

Application

BLA103780

Sponsor

SERONO INC

Original approval

March 7, 2002

Submission class

Type 1 - New Molecular Entity

Active ingredient

interferon beta-1a

Browse every approval whose brand starts with R, or the complete response letters FDA has published — the applications it did not approve.

Products under this application

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA records other approved supplements on this application, by the class code it assigns them: Labeling 11 · Supplement 1 · Manufacturing (CMC) 1. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

Other approvals to SERONO INC

• October 13, 2000NOVANTRONENDA021120