Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216196
Company: AGIOS PHARMS INC
Company: AGIOS PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PYRUKYND | MITAPIVAT SULFATE | EQ 5MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
PYRUKYND | MITAPIVAT SULFATE | EQ 20MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
PYRUKYND | MITAPIVAT SULFATE | EQ 50MG BASE | 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 |
---|---|---|---|---|---|---|---|
02/17/2022 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216196s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216196Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/216196Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/17/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216196s000lbl.pdf |