Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 219389
Company: SPRINGWORKS
Company: SPRINGWORKS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GOMEKLI | MIRDAMETINIB | 1MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| GOMEKLI | MIRDAMETINIB | 2MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 02/11/2025 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219389s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219389Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219379Orig1s000,219389Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/11/2025 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219389s000lbl.pdf |