FDA Approval for NEXLETOL issued to ESPERION THERAPS INC
$ESPR
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 211616
Company: ESPERION THERAPS INC
Company: ESPERION THERAPS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEXLETOL | BEMPEDOIC ACID | 180MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/21/2020 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211616s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211616Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211616Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2023 | SUPPL-15 |
Label is not available on this site. |
|||
| 09/20/2023 | SUPPL-14 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211616s014lbl.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-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211616s014lbl.pdf | |
| 02/21/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211616s000lbl.pdf |