FDA Approval for IGALMI issued to BIOXCEL THERAPEUTICS, INC.
$BTAI
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 215390
Company: BIOXCEL THERAPEUTICS, INC.
Company: BIOXCEL THERAPEUTICS, INC.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IGALMI | DEXMEDETOMIDINE | FILM;SUBLINGUAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/05/2022 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215390Orig1s000ltr.pdf |