FDA Approval for OTEZLA issued to AMGEN INC
$AMGN
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 205437
Company: AMGEN INC
Company: AMGEN INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OTEZLA | APREMILAST | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| OTEZLA | APREMILAST | 20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| OTEZLA | APREMILAST | 30MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/21/2014 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205437s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205437Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205437Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/25/2024 | SUPPL-13 | Efficacy-New Indication |
Label is not available on this site. |
||
| 07/20/2023 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205437s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205437Orig1s012ltr.pdf | |
| 12/20/2021 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205437s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205437Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/205437Orig1s011.pdf | |
| 04/10/2020 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205437Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205437Orig1s008ltr.pdf | |
| 07/19/2019 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205437Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205437Orig1s007ltr.pdf | |
| 06/29/2017 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205437s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205437Orig1s006ltr.pdf | |
| 12/21/2015 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205437s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205437Orig1s005ltr.pdf | |
| 04/27/2015 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/2014 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 07/20/2023 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205437s012lbl.pdf | |
| 12/20/2021 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205437s011lbl.pdf | |
| 04/10/2020 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205437Orig1s008lbl.pdf | |
| 07/19/2019 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205437Orig1s007lbl.pdf | |
| 06/29/2017 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205437s006lbl.pdf | |
| 12/21/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205437s005lbl.pdf | |
| 03/21/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205437s000lbl.pdf |
OTEZLA
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APREMILAST | APREMILAST | 10MG | TABLET;ORAL | Prescription | No | AB | 211761 | ALKEM LABS LTD |
| APREMILAST | APREMILAST | 10MG | TABLET;ORAL | Prescription | No | AB | 211878 | ANNORA |
| APREMILAST | APREMILAST | 10MG | TABLET;ORAL | Prescription | No | AB | 211674 | GLENMARK PHARMS LTD |
| APREMILAST | APREMILAST | 10MG | TABLET;ORAL | Prescription | No | AB | 211734 | MANKIND PHARMA |
| APREMILAST | APREMILAST | 10MG | TABLET;ORAL | Prescription | No | AB | 211774 | SHILPA |
| OTEZLA | APREMILAST | 10MG | TABLET;ORAL | Prescription | Yes | AB | 205437 | AMGEN INC |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APREMILAST | APREMILAST | 20MG | TABLET;ORAL | Prescription | No | AB | 211761 | ALKEM LABS LTD |
| APREMILAST | APREMILAST | 20MG | TABLET;ORAL | Prescription | No | AB | 211878 | ANNORA |
| APREMILAST | APREMILAST | 20MG | TABLET;ORAL | Prescription | No | AB | 211674 | GLENMARK PHARMS LTD |
| APREMILAST | APREMILAST | 20MG | TABLET;ORAL | Prescription | No | AB | 211734 | MANKIND PHARMA |
| APREMILAST | APREMILAST | 20MG | TABLET;ORAL | Prescription | No | AB | 211774 | SHILPA |
| OTEZLA | APREMILAST | 20MG | TABLET;ORAL | Prescription | Yes | AB | 205437 | AMGEN INC |
TABLET;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APREMILAST | APREMILAST | 30MG | TABLET;ORAL | Prescription | No | AB | 211761 | ALKEM LABS LTD |
| APREMILAST | APREMILAST | 30MG | TABLET;ORAL | Prescription | No | AB | 211878 | ANNORA |
| APREMILAST | APREMILAST | 30MG | TABLET;ORAL | Prescription | No | AB | 211674 | GLENMARK PHARMS LTD |
| APREMILAST | APREMILAST | 30MG | TABLET;ORAL | Prescription | No | AB | 211734 | MANKIND PHARMA |
| APREMILAST | APREMILAST | 30MG | TABLET;ORAL | Prescription | No | AB | 211774 | SHILPA |
| OTEZLA | APREMILAST | 30MG | TABLET;ORAL | Prescription | Yes | AB | 205437 | AMGEN INC |