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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212608
Company: BLUEPRINT MEDICINES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AYVAKIT AVAPRITINIB 100MG TABLET;ORAL Prescription None Yes No
AYVAKIT AVAPRITINIB 200MG TABLET;ORAL Prescription None Yes No
AYVAKIT AVAPRITINIB 300MG TABLET;ORAL Prescription None Yes Yes
AYVAKIT AVAPRITINIB 25MG TABLET;ORAL Prescription None Yes No
AYVAKIT AVAPRITINIB 50MG TABLET;ORAL Prescription None Yes 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
01/09/2020 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212608s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212608Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212608Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/16/2021 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212608Orig1s007ltr.pdf
06/16/2021 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212608Orig1s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/16/2021 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s007lbl.pdf
06/16/2021 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s006lbl.pdf
01/09/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212608s000lbl.pdf
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