New Drug Application (NDA): 213026
Company: SAREPTA THERAPS INC
Company: SAREPTA THERAPS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMONDYS 45 | CASIMERSEN | 100 mg/2 mL/VIAL | SOLUTION;INTRAVENOUS | Prescription | TBD | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 02/25/2021 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213026lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/25/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213026lbl.pdf |
AMONDYS 45
There are no Therapeutic Equivalents.