FDA Approval for RIFADIN issued to SANOFI AVENTIS US

10/11/24 11:21:40 AM ET

$SNY

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 050420
Company: SANOFI AVENTIS US

Products on NDA 050420

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIFADIN	RIFAMPIN	300MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050420

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/1971	ORIG-1	Approval		UNKNOWN	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050420Orig1s083, 050627Orig1s025ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2024	SUPPL-92		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050420s092,050627s037lbl.pdf
12/08/2023	SUPPL-91	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s091,050627s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050420Orig1s091; 050627Orig1s036ltr.pdf
08/16/2023	SUPPL-90	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s090,050627s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050420Orig1s090;050627Orig1s035ltr.pdf
02/17/2023	SUPPL-89	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s089,050627s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050420Orig1s089;050627Orig1s034ltr.pdf
02/10/2023	SUPPL-88	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s088,050627s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050420Orig1s088;050627Orig1s033ltr.pdf
01/29/2022	SUPPL-87	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050420s087,050627s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050420Orig1s087; 050627Orig1s030ltr.pdf
10/21/2021	SUPPL-86	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050420s086,050627s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050420Orig1s086,050627Orig1s029ltr.pdf
06/17/2021	SUPPL-85	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050420s085,050627s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050420Orig1s085; 050627Orig1s028ltr.pdf
05/12/2020	SUPPL-84	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050420s084,050627s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050420Orig1s084,050627Orig1s027ltr.pdf
08/27/2019	SUPPL-83	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s083,050627s025lbl.pdf
02/28/2019	SUPPL-80	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s080,050627s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050420Orig1s080, 050627Orig1s023ltr.pdf
01/23/2019	SUPPL-78	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s078,050627s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050420Orig1s078, 050627Orig1s021ltr.pdf
01/08/2018	SUPPL-77	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050420s077,050627s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050420Orig1s077, 050627Orig1s020ltr.pdf
04/24/2017	SUPPL-76	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/2017/050420s076,050627s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050627Orig1S017,050420Orig1S076ltr.pdf
02/27/2013	SUPPL-75	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050420Orig1s075,050627Orig1s014ltr.pdf
11/10/2010	SUPPL-73	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050420s073,050627s012ltr.pdf
08/20/2004	SUPPL-72	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50420s072,50627s008ltr.pdf
04/12/2000	SUPPL-71	Labeling		Label is not available on this site.
04/12/2000	SUPPL-70	Labeling		Label is not available on this site.
09/05/1995	SUPPL-68	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-67	Labeling		Label is not available on this site.
07/12/1994	SUPPL-66	Manufacturing (CMC)		Label is not available on this site.
01/05/1996	SUPPL-64	Manufacturing (CMC)-Control		Label is not available on this site.
06/18/1993	SUPPL-63	Labeling		Label is not available on this site.
10/20/1981	SUPPL-61	Manufacturing (CMC)		Label is not available on this site.
10/20/1981	SUPPL-60	Labeling		Label is not available on this site.
09/11/1982	SUPPL-59	Manufacturing (CMC)		Label is not available on this site.
12/31/1980	SUPPL-58	Manufacturing (CMC)-Control		Label is not available on this site.
07/25/1980	SUPPL-57	Manufacturing (CMC)-Control		Label is not available on this site.
10/29/1979	SUPPL-56	Manufacturing (CMC)		Label is not available on this site.
10/25/1979	SUPPL-55	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/25/1979	SUPPL-54	Labeling		Label is not available on this site.
05/01/1979	SUPPL-53	Labeling		Label is not available on this site.
04/16/1979	SUPPL-52	Labeling		Label is not available on this site.
04/16/1979	SUPPL-51	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/23/1979	SUPPL-50	Labeling		Label is not available on this site.
06/26/1979	SUPPL-49	Labeling		Label is not available on this site.
06/29/1978	SUPPL-48	Labeling		Label is not available on this site.
05/30/1978	SUPPL-47	Labeling		Label is not available on this site.
02/10/1978	SUPPL-46	Labeling		Label is not available on this site.
06/29/1977	SUPPL-45	Labeling		Label is not available on this site.
12/21/1976	SUPPL-44	Labeling		Label is not available on this site.
08/09/1976	SUPPL-43	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/03/1976	SUPPL-42	Manufacturing (CMC)-Control		Label is not available on this site.
03/01/1976	SUPPL-41	Manufacturing (CMC)-Control		Label is not available on this site.
02/18/1976	SUPPL-40	Labeling		Label is not available on this site.
01/28/1976	SUPPL-39	Labeling		Label is not available on this site.
01/19/1976	SUPPL-38	Labeling		Label is not available on this site.
03/29/1976	SUPPL-37	Labeling		Label is not available on this site.
08/28/1975	SUPPL-36	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/15/1975	SUPPL-35	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/16/1975	SUPPL-34	Labeling		Label is not available on this site.
01/30/1975	SUPPL-33	Labeling		Label is not available on this site.
11/26/1974	SUPPL-32	Labeling		Label is not available on this site.
05/21/1974	SUPPL-31	Labeling		Label is not available on this site.
05/29/1974	SUPPL-30	Labeling		Label is not available on this site.
03/28/1974	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
03/28/1974	SUPPL-28	Labeling		Label is not available on this site.
01/24/1974	SUPPL-27	Labeling		Label is not available on this site.
10/11/1973	SUPPL-26	Labeling		Label is not available on this site.
11/20/1973	SUPPL-25	Labeling		Label is not available on this site.
05/09/1973	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
01/19/1973	SUPPL-23	Labeling		Label is not available on this site.
10/05/1972	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/25/1972	SUPPL-21	Labeling		Label is not available on this site.
08/31/1972	SUPPL-20	Manufacturing (CMC)-Formulation		Label is not available on this site.
06/16/1972	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
03/22/1982	SUPPL-18	Labeling		Label is not available on this site.
01/26/1972	SUPPL-17	Labeling		Label is not available on this site.
12/06/1971	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
08/09/1971	SUPPL-15	Labeling		Label is not available on this site.
11/16/1987	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
05/18/1989	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
09/12/1984	SUPPL-12	Labeling		Label is not available on this site.
02/18/1986	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/08/1984	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/12/1990	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
09/02/1983	SUPPL-8	Labeling		Label is not available on this site.
02/12/1990	SUPPL-7	Labeling		Label is not available on this site.
05/25/1977	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
11/17/1982	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
11/15/1982	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/15/1982	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/26/1982	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
10/05/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050420

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2024	SUPPL-92	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050420s092,050627s037lbl.pdf
12/08/2023	SUPPL-91	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s091,050627s036lbl.pdf
08/16/2023	SUPPL-90	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s090,050627s035lbl.pdf
02/17/2023	SUPPL-89	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s089,050627s034lbl.pdf
02/10/2023	SUPPL-88	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050420s088,050627s033lbl.pdf
01/29/2022	SUPPL-87	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050420s087,050627s030lbl.pdf
10/21/2021	SUPPL-86	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050420s086,050627s029lbl.pdf
06/17/2021	SUPPL-85	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050420s085,050627s028lbl.pdf
05/12/2020	SUPPL-84	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050420s084,050627s027lbl.pdf
08/27/2019	SUPPL-83	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s083,050627s025lbl.pdf
02/28/2019	SUPPL-80	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s080,050627s023lbl.pdf
01/23/2019	SUPPL-78	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s078,050627s021lbl.pdf
01/08/2018	SUPPL-77	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050420s077,050627s020lbl.pdf
04/24/2017	SUPPL-76	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/2017/050420s076,050627s017lbl.pdf
02/27/2013	SUPPL-75	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf
11/10/2010	SUPPL-73	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf
08/20/2004	SUPPL-72	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf

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Date	Price Target	Rating	Analyst
7/26/2024	$55.00 → $60.00	Buy	Argus
1/23/2024	$55.00	Equal-Weight	Morgan Stanley
1/16/2024		Buy	UBS
12/5/2023		Overweight → Neutral	JP Morgan
10/30/2023		Buy → Hold	Stifel
9/6/2023		Hold → Buy	Berenberg
7/14/2023		Buy	HSBC Securities
4/28/2023		Hold → Sell	Deutsche Bank

FDA Approval for RIFADIN issued to SANOFI AVENTIS US

Products on NDA 050420

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050420

Original Approvals or Tentative Approvals

Supplements

Labels for NDA 050420

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