Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103628
Company: BIOGEN
Company: BIOGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AVONEX | INTERFERON BETA-1A | 30UG/ML | VIAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/17/1996 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/ifnbbio051796lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/ifnbbio051796l.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/103628Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/03/2021 | SUPPL-5266 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103628s5266lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103628Orig1s5266ltr.pdf | |
| 07/12/2019 | SUPPL-5264 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103628s5264lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103628Orig1s5264ltr.pdf | |
| 03/27/2020 | SUPPL-5263 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103628s5263lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103628Orig1s5263ltr.pdf | |
| 12/22/2015 | SUPPL-5258 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103628s5258lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103628Orig1s5258ltr.pdf | |
| 08/28/2014 | SUPPL-5224 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf | |
| 03/13/2013 | SUPPL-5206 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103628s5206lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103628Orig1s5206ltr.pdf | |
| 08/28/2014 | SUPPL-5194 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf | |
| 02/27/2012 | SUPPL-5191 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5191lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103628s5189,s5191ltr.pdf | |
| 02/27/2012 | SUPPL-5189 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5189lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103628s5189,s5191ltr.pdf | |
| 08/28/2014 | SUPPL-5177 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf | |
| 06/20/2007 | SUPPL-5132 | Supplement |
Label is not available on this site. |
||
| 08/28/2014 | SUPPL-5129 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf | |
| 02/02/2007 | SUPPL-5115 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103628s5115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103628s5115 ltr.pdf | |
| 02/23/2005 | SUPPL-5074 | Supplement |
Label is not available on this site. |
||
| 12/30/2004 | SUPPL-5069 | Supplement |
Label is not available on this site. |
||
| 03/26/2004 | SUPPL-5053 | Supplement |
Label is not available on this site. |
||
| 12/23/2003 | SUPPL-5050 | Supplement |
Label is not available on this site. |
||
| 05/28/2003 | SUPPL-5021 | Supplement |
Letter
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbbio052803L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103628s5021TOC.cfm |
| 11/12/2002 | SUPPL-5008 | Supplement |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbbio111202LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ifnbbio111202L.htm | |
| 01/31/2003 | SUPPL-5001 | Supplement |
Label
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbbio013103LB.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbbio013103L.htm | |
| 06/30/2000 | SUPPL-1025 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/03/2021 | SUPPL-5266 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103628s5266lbl.pdf | |
| 11/03/2021 | SUPPL-5266 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103628s5266lbl.pdf | |
| 03/27/2020 | SUPPL-5263 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103628s5263lbl.pdf | |
| 07/12/2019 | SUPPL-5264 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103628s5264lbl.pdf | |
| 07/12/2019 | SUPPL-5264 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103628s5264lbl.pdf | |
| 12/22/2015 | SUPPL-5258 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103628s5258lbl.pdf | |
| 08/28/2014 | SUPPL-5224 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf | |
| 08/28/2014 | SUPPL-5194 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf | |
| 08/28/2014 | SUPPL-5177 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf | |
| 08/28/2014 | SUPPL-5129 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf | |
| 03/13/2013 | SUPPL-5206 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103628s5206lbl.pdf | |
| 02/27/2012 | SUPPL-5191 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5191lbl.pdf | |
| 02/27/2012 | SUPPL-5189 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5189lbl.pdf | |
| 02/02/2007 | SUPPL-5115 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103628s5115lbl.pdf | |
| 01/31/2003 | SUPPL-5001 | Efficacy | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbbio013103LB.htm | ||
| 11/12/2002 | SUPPL-5008 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbbio111202LB.pdf | |
| 05/17/1996 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/ifnbbio051796lb.pdf |