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MUTAMYCIN

NDA

MITOMYCIN | N050450 | BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition Fresenius KabiUSA, LLC FDA-2018-P-0327 · 5 docket documents Fresenius Kabi USA, LLC filed this petition requesting that the FDA determine whether Mitomycin (NDA 050450, 5 mg/vial and 20 mg/vial) held by Bristol Laboratories Inc. was voluntarily withdrawn from sale for reasons of safety or efficacy, as required under 21 CFR 314.161 before an ANDA referring to	505(q)	2018-01-23	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

178 trials from ClinicalTrials.gov — 3 recruiting, 9 active, 85 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)NCT04241185	Phase 3	Active	Merck Sharp & Dohme LLC	520	2020-05-19 → 2031-11-01
Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer NCT03775265	Phase 3	Active	National Cancer Institute (NCI)	475	2019-06-03 → 2027-06-01
SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer NCT02299999	Phase 2	Active	UNICANCER	1,460	2014-04-07 → 2025-12
Proton Therapy in Reducing Toxicity in Anal Cancer NCT03018418	Phase 2	Active	Jordan Kharofa	14	2017-01-04 → 2025-07-01
A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial NCT04216290	Phase 2	Active	National Cancer Institute (NCI)	11	2021-03-17 → 2027-05-19
ICARuS Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis NCT01815359	Phase 2	Active	Memorial Sloan Kettering Cancer Center	292	2013-03 → 2026-09
Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. a Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group NCT04230759	Phase 2	Active	Goethe University	180	2020-01-07 → 2027-03-31
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study NCT04166318	Phase 2	Active	ECOG-ACRIN Cancer Research Group	252	2020-01-02 → 2029-12-31
Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life NCT02701088	Phase 2	Active	Centre Francois Baclesse	71	2015-12 → 2025-12
A Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study NCT03844256	Phase 1/2	Recruiting	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	50	2019-01-07 → 2026-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain6 active DMFs3 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVMITOMYCIN

DMF 137911998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMITOMYCIN USP (ALTERNATIVE PROCESS)

DMF 256592011

CONCORD BIOTECH LTDMITOMYCIN USP

DMF 336622019

CHEMWERTH INCMITOMYCIN

DMF 338112019

WUXI FORTUNE PHARMACEUTICAL CO LTDMITOMYCIN

DMF 348662020

HUBEI HONCH PHARMACEUTICAL CO LTDMITOMYCIN

DMF 374622023

KYOWA HAKKO KOGYO CO LTDInactiveMITOMYCIN

DMF 135211998

MICROBIOPHARM JAPAN CO LTDInactiveMITOMYCIN

DMF 137851998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveMITOMYCIN USP

DMF 137831998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982