Rebif

Treats relapsing forms of multiple sclerosis (MS). BLA 103780, held by Serono Inc. Interferon Beta-1a.

As of Nov 14, 2026, BLA 103780 (Rebif), held by Serono Inc, was first approved by FDA on Mar 7, 2002, with 17 approved supplements and 0 published complete response letters.

First approved: Mar 7, 2002
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Rebif is an interferon beta

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


May 26, 2020	Supplement 5203Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 27, 2016	Supplement 5196Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Mar 26, 2004	Supplement 5027Efficacy (new indication or use) · Standard review	Approved	None posted
May 2, 2003	Supplement 5010Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 7, 2002	Original applicationNew molecular entity	Approved	Letter Label

Products

2 strengths and forms


Rebif22UG/0.5ML · syringe	Interferon Beta-1a	Rx
Rebif44UG/0.5ML · syringe	Interferon Beta-1a	Rx

All 18 submissions, including labeling and manufacturing supplements


Jul 28, 2023	Supplement 5214Labeling · Standard review	Approved	Label Medication Guide Letter
Nov 3, 2021	Supplement 5210Labeling · Standard review	Approved	Letter Label
May 26, 2020	Supplement 5207Labeling · Standard review	Approved	Letter Label
May 26, 2020	Supplement 5203Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 9, 2019	Supplement 5204Labeling · Standard review	Approved	Label Letter
Sep 27, 2016	Supplement 5196Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 22, 2015	Supplement 5194Labeling · Standard review	Approved	Label Letter
Mar 10, 2015	Supplement 5172Labeling · Standard review	Approved	Label Letter
Apr 24, 2014	Supplement 5179Labeling · Standard review	Approved	Label Letter
Apr 24, 2014	Supplement 5178Labeling · Standard review	Approved	Label Letter
Apr 19, 2013	Supplement 5140Labeling · Standard review	Approved	Letter Label
Dec 21, 2012	Supplement 5121Manufacturing	Approved	Letter Label
Jun 30, 2005	Supplement 5062Labeling · Standard review	Approved	Label Letter
Dec 23, 2004	Supplement 5030Labeling · Standard review	Approved	Label Letter
Dec 17, 2004	Supplement 5052	Approved	Label Letter
Mar 26, 2004	Supplement 5027Efficacy (new indication or use) · Standard review	Approved	None posted
May 2, 2003	Supplement 5010Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 7, 2002	Original applicationNew molecular entity	Approved	Letter Label

Identifiers

Application: BLA 103780
Drugs@FDA: Overview at FDA
Company: Serono

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters