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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201699
Company: CUBIST PHARMS LLC

Summary Review

Products on NDA 201699

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIFICID	FIDAXOMICIN	200MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201699

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201699s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201699s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2020	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201699s013,213138s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201699Orig1s013,213138Orig1s001ltr.pdf
01/24/2020	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201699s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201699Orig1s012ltr.pdf
04/05/2019	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201699Orig1s011ltr.pdf
03/15/2019	SUPPL-10	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201699Orig1s010ltr.pdf
02/24/2015	SUPPL-9	Efficacy-Pediatric	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201699Orig1s009ltr.pdf
11/18/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/06/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/21/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/04/2013	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201699s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201699Orig1s004ltr_corrected.pdf
12/19/2012	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 201699

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2020	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201699s013,213138s001lbl.pdf
05/28/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201699s013,213138s001lbl.pdf
01/24/2020	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201699s012lbl.pdf
04/05/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s011lbl.pdf
04/05/2019	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s011lbl.pdf
03/15/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s010lbl.pdf
03/15/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s010lbl.pdf
04/04/2013	SUPPL-4	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201699s004lbl.pdf
05/27/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201699s000lbl.pdf

Therapeutic Equivalents for NDA 201699

DIFICID

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFICID	FIDAXOMICIN	200MG	TABLET;ORAL	Prescription	Yes	AB	201699	CUBIST PHARMS LLC
FIDAXOMICIN	FIDAXOMICIN	200MG	TABLET;ORAL	Prescription	No	AB	208443	ACTAVIS LABS FL
FIDAXOMICIN	FIDAXOMICIN	200MG	TABLET;ORAL	Prescription	No	AB	219559	APOTEX
FIDAXOMICIN	FIDAXOMICIN	200MG	TABLET;ORAL	Prescription	No	AB	220374	TORRENT

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