← FDA DRUG APPROVALS

FDA BLA · BLA103628

AVONEX

interferon beta-1a

Sponsor: BIOGEN

APPLICATION
BLA103628
TYPE
BLA
ORIGINAL APPROVAL
1996-05-17
LATEST ACTION
2023-07-28
ROUTE
INTRAMUSCULAR
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

AVONEXPrescription
INTERFERON BETA-1A 30UG/ML · VIAL

Approval history

2023-07-28Labeling · Supplement 5269 · standard — Label ↗AP
2021-11-03Labeling · Supplement 5266 · 901 required — Letter ↗AP
2020-03-27Efficacy · Supplement 5263 · standard — Letter ↗AP
2019-07-12Labeling · Supplement 5264 · standard — Label ↗AP
2015-12-22Labeling · Supplement 5258 · standard — Letter ↗AP
2014-08-28Labeling · Supplement 5129 · standard — Label ↗AP
2014-08-28Labeling · Supplement 5224 · standard — Label ↗AP
2014-08-28Labeling · Supplement 5194 · standard — Letter ↗AP
2014-08-28Labeling · Supplement 5177 · standard — Label ↗AP
2013-03-13Labeling · Supplement 5206 · standard — Label ↗AP
2012-02-27Efficacy · Supplement 5189 · standard — Label ↗AP
2012-02-27Efficacy · Supplement 5191 — Label ↗AP
2007-06-20Labeling · Supplement 5132 · standardAP
2007-02-02Labeling · Supplement 5115 · standard — Label ↗AP
2005-02-23Labeling · Supplement 5074 · standardAP
2004-12-30Labeling · Supplement 5069 · standardAP
2004-03-26Labeling · Supplement 5053 · standardAP
2003-12-23Labeling · Supplement 5050 · standardAP
2003-05-28Supplement · Supplement 5021 — Review ↗AP
2003-01-31Efficacy · Supplement 5001 · standard — Label ↗AP
2002-11-12Efficacy · Supplement 5008 · standard — Label ↗AP
2000-06-30Labeling · Supplement 1025 · standardAP
1996-05-17Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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