Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204026
Company: BRISTOL
Company: BRISTOL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POMALYST | POMALIDOMIDE | 1MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| POMALYST | POMALIDOMIDE | 2MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| POMALYST | POMALIDOMIDE | 3MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| POMALYST | POMALIDOMIDE | 4MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 02/08/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-31 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204026s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204026Orig1s031ltr.pdf | |
| 08/05/2021 | SUPPL-29 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204026Orig1s029ltr.pdf |
| 12/03/2020 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204026Orig1s028ltr.pdf | |
| 11/20/2020 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204026Orig1s027ltr.pdf | |
| 05/14/2020 | SUPPL-24 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204026Orig1s024ltr.pdf | |
| 05/14/2020 | SUPPL-23 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204026Orig1s023ltr.pdf | |
| 10/30/2019 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204026s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204026Orig1s021ltr.pdf | |
| 12/29/2017 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s019ltr.pdf | |
| 11/30/2017 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s018ltr.pdf | |
| 03/20/2018 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204026s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204026Orig1s017ltr.pdf | |
| 06/27/2017 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s016ltr.pdf |
| 06/30/2016 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf | |
| 04/22/2016 | SUPPL-13 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s013ltr.pdf |
| 06/30/2016 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf | |
| 12/01/2015 | SUPPL-11 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s011ltr.pdf |
| 10/27/2015 | SUPPL-10 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s010ltr.pdf |
| 09/14/2015 | SUPPL-9 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s009ltr.pdf |
| 04/23/2015 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf | |
| 04/23/2015 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf | |
| 04/23/2015 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf | |
| 09/12/2014 | SUPPL-4 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s004ltr.pdf |
| 03/13/2014 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204026s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s003ltr.pdf | |
| 11/15/2013 | SUPPL-2 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s002ltr.pdf |
| 10/03/2013 | 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 |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-31 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204026s031lbl.pdf | |
| 12/03/2020 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s028lbl.pdf | |
| 11/20/2020 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s027lbl.pdf | |
| 05/14/2020 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s024lbl.pdf | |
| 05/14/2020 | SUPPL-23 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s023lbl.pdf | |
| 10/30/2019 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204026s021lbl.pdf | |
| 03/20/2018 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204026s017lbl.pdf | |
| 12/29/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s019lbl.pdf | |
| 11/30/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s018lbl.pdf | |
| 06/30/2016 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf | |
| 06/30/2016 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf | |
| 04/23/2015 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf | |
| 04/23/2015 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf | |
| 04/23/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf | |
| 03/13/2014 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204026s003lbl.pdf | |
| 02/08/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204026lbl.pdf |
POMALYST
CAPSULE;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POMALIDOMIDE | POMALIDOMIDE | 1MG | CAPSULE;ORAL | Prescription | No | AB | 210164 | APOTEX |
| POMALIDOMIDE | POMALIDOMIDE | 1MG | CAPSULE;ORAL | Prescription | No | AB | 210236 | HETERO LABS LTD V |
| POMALYST | POMALIDOMIDE | 1MG | CAPSULE;ORAL | Prescription | Yes | AB | 204026 | BRISTOL |
CAPSULE;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POMALIDOMIDE | POMALIDOMIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 210164 | APOTEX |
| POMALIDOMIDE | POMALIDOMIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 210236 | HETERO LABS LTD V |
| POMALYST | POMALIDOMIDE | 2MG | CAPSULE;ORAL | Prescription | Yes | AB | 204026 | BRISTOL |
CAPSULE;ORAL; 3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POMALIDOMIDE | POMALIDOMIDE | 3MG | CAPSULE;ORAL | Prescription | No | AB | 210164 | APOTEX |
| POMALIDOMIDE | POMALIDOMIDE | 3MG | CAPSULE;ORAL | Prescription | No | AB | 210236 | HETERO LABS LTD V |
| POMALYST | POMALIDOMIDE | 3MG | CAPSULE;ORAL | Prescription | Yes | AB | 204026 | BRISTOL |
CAPSULE;ORAL; 4MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POMALIDOMIDE | POMALIDOMIDE | 4MG | CAPSULE;ORAL | Prescription | No | AB | 210164 | APOTEX |
| POMALIDOMIDE | POMALIDOMIDE | 4MG | CAPSULE;ORAL | Prescription | No | AB | 210236 | HETERO LABS LTD V |
| POMALYST | POMALIDOMIDE | 4MG | CAPSULE;ORAL | Prescription | Yes | AB | 204026 | BRISTOL |