Novantrone - 批准函（补充申请/孤儿药指定）

Aug 21, 2026

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Approval package letters from the Center for Drug Evaluation and Research address Immunex Corporation’s new drug application and supplemental approval for Novantrone (mitoxantrone for injection concentrate). The correspondence confirms safe and effective use when administered in combination with corticosteroids as initial chemotherapy for pain related to advanced hormone-refractory prostate cancer, and provides requirements for final printed labeling and promotional materials submissions. A separate letter grants orphan drug designation for mitoxantrone for hormone-refractory prostate cancer and outlines obligations regarding orphan exclusivity notifications and annual development status updates.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages382

Reading Time16 h 3 min

AccessFree to download

Approval Package

New Drug Application Supplemental Approval (NDA 19-297/S-014)

Final Printed Labeling and Promotional Materials

Orphan Drug Designation Notification

# CENTER FOR DRUG EVAILUATION AND RESEARCH APPROVAL PACKAGE for: APPLICATION NIJMBER:019297/S014 TRADE NAME:Novantrone GENERIC NAME:Mixtoxantrone for injection concentrate Immunex Corporation SPONSOR: APPROVALDATE: 11/13/96 Food and Drug AdministrationRockville MD 20857 Immunex Corporation51University StreetSeattle,Washington 98101-2936 3V1 I9CS Attention:Mark W.GauthierSenior Regulatory Affairs Manager Dear Mr.Gauthier: Please refer to your May 10,1996 new drug application submitted under section 505(b)of theFederal Food,Drug,and Cosmetic Act for Novantrone(mitoxantrone for injectionconcentrate). We acknowledge receipt of your amendments dated July 10;August 16;September 6 and 19;October 1,3,11,18 and 31;and November 11,1996. This new drug application provides for the use of Novantrone in combination withcorticosteroids as initial chemotherapy for the treatment of patients with pain related toadvanced hormone-refractory prostate cancer. We have completed the review of this supplemental application,including the submitted draftlabeling,and have concluded that adequate information has been presented to demonstrate thatthe drug product is safe and effective for use as recommended in the enclosed marked-up draftlabeling.Accordingly,the application is approved effective on the date of this letter. The final printed labeling (FPL)must be identical to the enclosed marked-up draft labeling. Please submit sixteen copies of the FPL as soon as it is available,in no case more than 30 daysafter it is printed.Please individually mount ten of the copies on heavy weight paper orsimilar material.For administrative purposes this submission should be designated "FINALPRINTED LABELING"for approved NDA 19-297/S-014.Approval of this submission byFDA is not required before the labeling is used. Should additional information relating to the safety and effectiveness of the drug becomeavailable,revision of that labeling may be required. In addition,please submit thre copies of the introductory promotional material that youpropose to use for this product.All proposed materials should be submitted in draft or mock-up form,not final print.Please submit one copy to this Division and two copies of both thepromotional material and the package insert directly to: Food and Drug Administration Division of Drug Marketing,Advertising and Communications,HFD-40 5600 Fishers LaneRockville,Maryland 20857 We remind you that you must comply with the requirements for an approved NDA set forthunder 21 CFR 314.80 and 314.81. If you have any questions,please contact Leslie Vaccari,Project Manager,(301)594-5778. Relu4从f4 1-3-96 Robert J.DeLap,M.D.,Ph.D.Director Division of Oncology Drug ProductsOffice of Drug Evaluation ICenter for Drug Evaluation and Research ENCLOSURE:Labeling NDA19-297/S-014Page 3 Cc: Original NDA 19-297HFD-150/Div.filesHFD-2/M.LumpkinHFD-101/L.CarterHFD-810/C.HoibergDISTRICT OFFICEHFD-80(with labeling) HFD-35/PVaccari(with labeling)HFD-40/DDMAC/TAcker(with labeling)HFD-613(with labeling)HFD-021/J.Treacy(with labeling)HFD-150/LVaccari(with labeling)HFD-150/JBeitz(with labeling)HFD-150/GeWilliams(with labeling)HFD-150/RBarron(with labeling)HFD-150/TKoutouskos(with labeling)HFD-150/DPease(with labeling) Drafted by:LVaccari/11-9-96/FT:11-13-96R/D Init.by:DPease/11-12-96,11-1子-96 JBeitz/11-13-96 RJustice/11-13-96 RBarron/11-13-96 RWood/11-13-96 GeWilliams/11-12-96 ARahman/11-13-96 JDeGeorge/11-13-96 TKoutsoukos/11-12-96 CGnecco/11-12-96 final: APPROVAL(Efficacy Supplement/S-014) Office of Orphan Products Development(HF-35)Food and Drug Administratior 5600 Fishers LaneRockville,MD 20857 August 21,1996 Immunex Corporation Attention:Mr.Mark W.GauthierSenior Manager,Regulatory Affairs51 University StreetSeattle,WA 98101 Dear Mr.Gauthier: Reference is made to your orphan drug application of April 3,1996 submi

FAQs

该批准函确认了Novantrone的哪些用途？

函件确认Novantrone与糖皮质激素联合用作晚期激素难治性前列腺癌患者疼痛相关的初始化疗方案的用途，并认定药品按附件标注推荐使用时具备安全性与有效性所需的充分信息。

最终印刷标签（FPL）需要满足什么要求？

最终印刷标签必须与所附标注的修订草案保持一致，并要求按规定份数提交，同时在行政用途上指定为“FINAL PRINTED LABELING”。

孤儿药指定信中对申请方有哪些后续义务？

指定信要求在行使孤儿药独占性意向时提交书面通知，并在开发项目状态方面至少按年度告知该办公室；同时在提交后续营销申请时需对应孤儿指定用途进行指示与必要的数据补充。

Aug 21, 2026

Upload by Levi