Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103780
Company: SERONO INC
Company: SERONO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REBIF | INTERFERON BETA-1A | 22UG/0.5ML | SYRINGE | Prescription | None | No | No |
| REBIF | INTERFERON BETA-1A | 44UG/0.5ML | SYRINGE | 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 |
|---|---|---|---|---|---|---|---|
| 03/07/2002 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbser030702LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ifnbser030702L.htm https://web.archive.org/web/20170118085129/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080737.htm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/28/2023 | SUPPL-5214 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103780s5214lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103780Orig1s5214ltr.pdf | |
| 11/03/2021 | SUPPL-5210 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103780s5210lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103780Orig1s5210ltr.pdf | |
| 05/26/2020 | SUPPL-5207 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103780s5203s5207lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103780Orig1s5203s5207ltr.pdf | |
| 07/09/2019 | SUPPL-5204 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103780s5204lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103780Orig1s5204ltr.pdf | |
| 05/26/2020 | SUPPL-5203 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103780s5203s5207lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103780Orig1s5203s5207ltr.pdf | |
| 09/27/2016 | SUPPL-5196 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103780s5196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103780Orig1s5196ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/103780Orig1s5196.pdf | |
| 12/22/2015 | SUPPL-5194 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5194lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103780Orig1s5194ltr.pdf | |
| 04/24/2014 | SUPPL-5179 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103780Orig1s5178,s5179ltr.pdf | |
| 04/24/2014 | SUPPL-5178 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103780Orig1s5178,s5179ltr.pdf | |
| 03/10/2015 | SUPPL-5172 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103780Orig1s5172ltr.pdf | |
| 04/19/2013 | SUPPL-5140 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103780s5140lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103780Orig1s5140ltr.pdf | |
| 12/21/2012 | SUPPL-5121 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103780s5121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103780Orig1s5121ltr.pdf | |
| 06/30/2005 | SUPPL-5062 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103780s5062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103780s5062ltr.pdf | |
| 12/17/2004 | SUPPL-5052 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103780_5052ltr.pdf | |
| 12/23/2004 | SUPPL-5030 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103780_5030ltr.pdf | |
| 03/26/2004 | SUPPL-5027 | Supplement |
Label is not available on this site. |
||
| 05/02/2003 | SUPPL-5010 | Supplement |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbser050203LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbser050203L.htm https://web.archive.org/web/20120303004314/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080739.htm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/28/2023 | SUPPL-5214 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103780s5214lbl.pdf | |
| 07/28/2023 | SUPPL-5214 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103780s5214lbl.pdf | |
| 11/03/2021 | SUPPL-5210 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103780s5210lbl.pdf | |
| 11/03/2021 | SUPPL-5210 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103780s5210lbl.pdf | |
| 05/26/2020 | SUPPL-5207 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103780s5203s5207lbl.pdf | |
| 05/26/2020 | SUPPL-5203 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103780s5203s5207lbl.pdf | |
| 07/09/2019 | SUPPL-5204 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103780s5204lbl.pdf | |
| 07/09/2019 | SUPPL-5204 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103780s5204lbl.pdf | |
| 09/27/2016 | SUPPL-5196 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103780s5196lbl.pdf | |
| 12/22/2015 | SUPPL-5194 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5194lbl.pdf | |
| 03/10/2015 | SUPPL-5172 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5172lbl.pdf | |
| 04/24/2014 | SUPPL-5179 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf | |
| 04/24/2014 | SUPPL-5178 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf | |
| 04/19/2013 | SUPPL-5140 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103780s5140lbl.pdf | |
| 12/21/2012 | SUPPL-5121 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103780s5121lbl.pdf |
| 06/30/2005 | SUPPL-5062 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103780s5062lbl.pdf | |
| 12/23/2004 | SUPPL-5030 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5030lbl.pdf | |
| 12/17/2004 | SUPPL-5052 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5052lbl.pdf | |
| 05/02/2003 | SUPPL-5010 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbser050203LB.pdf | |
| 03/07/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbser030702LB.pdf |