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TOTECT

NDA

DEXRAZOXANE HYDROCHLORIDE | N022025 | CLINIGEN INC

1 strength0 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 from Cardinal Health Regulatory Sciences FDA-2021-P-1354 · 6 docket documents Cardinal Health Regulatory Sciences filed this citizen petition requesting that the FDA Commissioner determine whether TOTECT (Dexrazoxane) for Injection, 500MG BASE/VIAL under NDA 022025 held by Clinigen Inc was voluntarily withdrawn for safety or effectiveness reasons. The petitioner asserts the d	505(q)	2021-12-27	Granted	Cardinal Health Regulatory Sciences

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

Clinical Trials

47 trials from ClinicalTrials.gov — 3 recruiting, 6 active, 23 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia NCT03164057	Phase 2	Active	St. Jude Children's Research Hospital	206	2017-06-15 → 2027-06
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia NCT03007147	Phase 3	Active	Children's Oncology Group	475	2017-08-08 → 2027-09-30
Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma NCT01864109	Phase 2	Active	Memorial Sloan Kettering Cancer Center	83	2013-05 → 2027-05
Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma NCT00077285	Phase 2	Active	Memorial Sloan Kettering Cancer Center	65	2003-10 → 2027-10
Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents NCT03020030	Phase 3	Active	Dana-Farber Cancer Institute	560	2017-03-03 → 2034-11
Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy NCT01871766	Phase 2	Active	St. Jude Children's Research Hospital	115	2013-12-04 → 2030-06
Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers NCT03589729	Phase 2	Recruiting	M.D. Anderson Cancer Center	100	2018-09-19 → 2027-12-31
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations NCT04293562	Phase 3	Recruiting	Children's Oncology Group	1,186	2020-07-21 → 2029-06-30
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)NCT03126916	Phase 3	Recruiting	Children's Oncology Group	750	2018-05-14 → 2030-09-30
Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors NCT00039481	Phase 1	Completed	National Cancer Institute (NCI)	15	2002-11

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

API Supply Chain8 active DMFs1 inactive

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

STERLING WISCONSIN LLCDEXRAZOXANE (FP-048)

DMF 183362005

TAPI NL BVDEXRAZOXANE (ICRF-187)

DMF 190022005

BIOCARE PHARMACEUTICAL LTDDEXRAZOXANE, NON-STERILE BULK DRUG SUBSTANCE

DMF 215422008

GLAND PHARMA LTDDEXRAZOXANE

DMF 231722009

GLAND PHARMA LTDDEXRAZOXANE (PROCESS-II)

DMF 278262014

MSN LABORATORIES PRIVATE LTDDEXRAZOXANE

DMF 346942020

APITORIA PHARMA PRIVATE LTDDEXRAZOXANE

DMF 377162022

PORTON PHARMA SOLUTIONS LTDDEXRAZOXANE

DMF 381862023

BOEHRINGER INGELHEIM CHEMICALS INCInactiveDEXRAZOXANE

DMF 151842000

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Nov 17, 2020	SUPPL -19	View Letter (PDF)
Nov 20, 2018	SUPPL -18	View Letter (PDF)
Feb 9, 2018	SUPPL -16	View Letter (PDF)
Apr 30, 2013	SUPPL -13	View Letter (PDF)
Mar 10, 2011	SUPPL -11	View Letter (PDF)
Nov 10, 2009	SUPPL -5	View Letter (PDF)
Feb 18, 2009	SUPPL -1	View Letter (PDF)
Sep 11, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 6, 2007

No patent or exclusivity listings for this strength.