Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125499
Company: BIOGEN IDEC INC
Company: BIOGEN IDEC INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PLEGRIDY | PEGINTERFERON BETA-1A | 125MICROGRAMS/0.5ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
08/15/2014 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125499s000ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/28/2023 | SUPPL-28 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125499s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125499Orig1s028ltr.pdf | |
03/29/2022 | SUPPL-25 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125499s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125499Orig1s025ltr.pdf | |
11/03/2021 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125499Orig1s023tr.pdf | |
01/29/2021 | SUPPL-21 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125499Orig1s021ltr.pdf | |
07/10/2019 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125499s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125499Orig1s019ltr.pdf | |
03/27/2020 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125499s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125499Orig1s018ltr.pdf | |
07/14/2016 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125499Orig1s011ltr.pdf | |
12/22/2015 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125499s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125499s009ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/28/2023 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125499s028lbl.pdf | |
07/28/2023 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125499s028lbl.pdf | |
03/29/2022 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125499s025lbl.pdf | |
11/03/2021 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s023lbl.pdf | |
11/03/2021 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s023lbl.pdf | |
01/29/2021 | SUPPL-21 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s021lbl.pdf | |
03/27/2020 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125499s018lbl.pdf | |
07/10/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125499s019lbl.pdf | |
07/10/2019 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125499s019lbl.pdf | |
07/14/2016 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf | |
07/14/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf | |
12/22/2015 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125499s009lbl.pdf | |
08/15/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499lbl.pdf |