FDA Approval for NEXLIZET issued to ESPERION THERAPS INC
$ESPR
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 211617
Company: ESPERION THERAPS INC
Company: ESPERION THERAPS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEXLIZET | BEMPEDOIC ACID; EZETIMIBE | 180MG;10MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/2020 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211617s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211617Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211617Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2023 | SUPPL-19 |
Label is not available on this site. |
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| 09/20/2023 | SUPPL-18 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211616Orig1s014;211617Orig1s018ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/20/2023 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s018lbl.pdf | |
| 02/26/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211617s000lbl.pdf |