Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761079
Company: BIOMARIN PHARM
Company: BIOMARIN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PALYNZIQ | PEGVALIASE-PQPZ | 2.5MG/O.5ML | INJECTABLE;INJECTION | Prescription | None | No | No |
PALYNZIQ | PEGVALIASE-PQPZ | 10MG/0.5ML | INJECTABLE;INJECTION | Prescription | None | No | No |
PALYNZIQ | PEGVALIASE-PQPZ | 20MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
05/24/2018 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761079Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761079Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/20/2020 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761079s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761079Orig1s010ltr.pdf | |
10/06/2020 | SUPPL-7 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761079Orig1s005,s006,s007ltr.pdf |
10/06/2020 | SUPPL-6 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761079Orig1s005,s006,s007ltr.pdf |
10/06/2020 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761079s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761079Orig1s005,s006,s007ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/20/2020 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761079s010lbl.pdf | |
10/06/2020 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761079s005lbl.pdf | |
05/24/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf |