FDA Approval for TECFIDERA issued to BIOGEN INC
$BIIB
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 204063
Company: BIOGEN INC
Company: BIOGEN INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TECFIDERA | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | AB | Yes | No |
| TECFIDERA | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/27/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204063Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2023 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204063s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204063Orig1s032ltr.pdf | |
| 03/12/2024 | SUPPL-31 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204063s031lbl.pdf | ||
| 09/29/2022 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204063s028s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204063Orig1s028, s030ltr.pdf | |
| 02/10/2023 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204063s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204063Orig1s029ltr.pdf | |
| 09/29/2022 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204063s028s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204063Orig1s028, s030ltr.pdf | |
| 02/10/2022 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204063s027lbl.pdf | |
| 01/29/2021 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204063s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204063Orig1s026ltr.pdf | |
| 12/11/2019 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204063s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204063Orig1s025ltr.pdf | |
| 07/10/2019 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204063s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204063Orig1s024ltr.pdf | |
| 02/05/2020 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204063s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204063Orig1s023ltr.pdf | |
| 12/15/2017 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204063Orig1s020ltr.pdf | |
| 01/19/2017 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204063Orig1s017ltr.pdf | |
| 12/24/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/29/2016 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204063s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204063Orig1s014ltr.pdf | |
| 10/16/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/2014 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204063Orig1s010.pdf | |
| 11/14/2014 | SUPPL-9 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s009ltr.pdf |
| 12/03/2014 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf | |
| 03/06/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/2014 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/2014 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf | |
| 08/20/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204063s031lbl.pdf | |
| 12/13/2023 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204063s032lbl.pdf | |
| 02/10/2023 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204063s029lbl.pdf | |
| 09/29/2022 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204063s028s030lbl.pdf | |
| 09/29/2022 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204063s028s030lbl.pdf | |
| 02/10/2022 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204063s027lbl.pdf | |
| 01/29/2021 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204063s026lbl.pdf | |
| 02/05/2020 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204063s023lbl.pdf | |
| 12/11/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204063s025lbl.pdf | |
| 07/10/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204063s024lbl.pdf | |
| 12/15/2017 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s020lbl.pdf | |
| 01/19/2017 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s017lbl.pdf | |
| 02/29/2016 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204063s014lbl.pdf | |
| 12/03/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf | |
| 12/03/2014 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf | |
| 12/03/2014 | SUPPL-8 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf | |
| 12/03/2014 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf | |
| 03/27/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf |
TECFIDERA
CAPSULE, DELAYED RELEASE;ORAL; 120MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210499 | ACCORD HLTHCARE |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210440 | ALKEM LABS LTD |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210402 | AMNEAL |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210385 | AUROBINDO PHARMA |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210305 | CIPLA |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210309 | GLENMARK PHARMS LTD |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210500 | HETERO LABS LTD III |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210226 | LUPIN |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210460 | MSN |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210531 | MYLAN |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210414 | PRINSTON INC |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210436 | SOLA PHARMS |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210382 | TWI PHARMS |
| TECFIDERA | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 204063 | BIOGEN INC |
CAPSULE, DELAYED RELEASE;ORAL; 240MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210499 | ACCORD HLTHCARE |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210440 | ALKEM LABS LTD |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210402 | AMNEAL |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210385 | AUROBINDO PHARMA |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210305 | CIPLA |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210309 | GLENMARK PHARMS LTD |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210500 | HETERO LABS LTD III |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210226 | LUPIN |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210460 | MSN |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210531 | MYLAN |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210414 | PRINSTON INC |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210436 | SOLA PHARMS |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 210382 | TWI PHARMS |
| TECFIDERA | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 204063 | BIOGEN INC |