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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206426
Company: BIOCRYST

Summary Review

Products on NDA 206426

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RAPIVAB	PERAMIVIR	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206426Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2024	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206426s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206426Orig1s009ltr.pdf
01/28/2021	SUPPL-7	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206426s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206426Orig1s007ltr.pdf
05/03/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206426s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206426Orig1s005ltr.pdf
09/20/2017	SUPPL-4	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206426s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206426Orig1s004ltr.pdf
08/12/2016	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206426s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206426Orig1s003ltr.pdf
11/02/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/11/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 206426

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206426s009lbl.pdf
01/28/2021	SUPPL-7	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206426s007lbl.pdf
05/03/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206426s005lbl.pdf
09/20/2017	SUPPL-4	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206426s004lbl.pdf
08/12/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206426s003lbl.pdf
12/19/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf

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