FDA Approval for BYLVAY issued to ALBIREO PHARMA INC
$ALBO
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 215498
Company: ALBIREO PHARMA INC
Company: ALBIREO PHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BYLVAY | ODEVIXIBAT | 400MCG | CAPSULE;ORAL | Prescription | None | No | No |
| BYLVAY | ODEVIXIBAT | 1200MCG | CAPSULE;ORAL | Prescription | None | No | No |
| BYLVAY | ODEVIXIBAT | 200MCG | PELLETS;ORAL | Prescription | None | No | No |
| BYLVAY | ODEVIXIBAT | 600MCG | PELLETS;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/20/2021 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215498s000lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/20/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215498s000lbl.pdf |