FDA Approval for NUPLAZID issued to ACADIA PHARMS INC
$ACAD
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 207318
Company: ACADIA PHARMS INC
Company: ACADIA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUPLAZID | PIMAVANSERIN TARTRATE | EQ 17MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| NUPLAZID | PIMAVANSERIN TARTRATE | EQ 10MG BASE | TABLET;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 04/29/2016 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207318Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207318Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207318Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/15/2023 | SUPPL-12 |
Label is not available on this site. |
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| 11/23/2020 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207318s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207318Orig1s010, 210793Orig1s007ltr.pdf | |
| 09/27/2019 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s009,210793s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207318Orig1s009, 210793Orig1s003ltr.pdf | |
| 05/10/2019 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s007,210793s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207318Orig1s007, 210793Orig1s002ltr.pdf | |
| 03/04/2019 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s006,210793s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207318Orig1s006,210793Orig1s001ltr.pdf | |
| 06/06/2018 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s005ltr.pdf | |
| 03/04/2018 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s002s004ltr.pdf | |
| 06/28/2018 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210793_207318s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210793Orig1s000,207318Orig1s003ltr.pdf | |
| 03/04/2018 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s002s004ltr.pdf | |
| 10/17/2017 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207318s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207318Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/23/2020 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207318s010lbl.pdf | |
| 09/27/2019 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s009,210793s003lbl.pdf | |
| 05/10/2019 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s007,210793s002lbl.pdf | |
| 03/04/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s006,210793s001lbl.pdf | |
| 06/28/2018 | SUPPL-3 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210793_207318s003lbl.pdf | |
| 06/06/2018 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s005lbl.pdf | |
| 03/04/2018 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf | |
| 03/04/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf | |
| 10/17/2017 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207318s001lbl.pdf | |
| 04/29/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf |