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Withdrawn Drug Applications

Drugs with withdrawn or discontinued regulatory applications in the US or EU — useful for competitive and label-history research.

Quick answer

Withdrawn applications: NovaPharmaNews tracks 229 pharmaceutical drugs in this segment. Drugs with withdrawn or discontinued regulatory applications in the US or EU — useful for competitive and label-history research.

229 drugs · Withdrawn · by data quality · Page 1 of 10

  1. adenovirus-mediated herpes simplex virus-thymidine kinase gene

    CEREPRO Ark Therapeutics

    EMA: application withdrawn

  2. allopurinol

    ALLOPURINOL SANDOZ Alphapharm Pty Ltd

    ORAL FDA: approved · EMA: withdrawn · TGA: approved · NMPA: clinical trials

    M04AA51

  3. apomorphine

    APOMINE INTERMITTENT STADA Pharmaceuticals Australia Pty Limited

    EMA: withdrawn · TGA: approved

    G04BE

  4. beclomethasone dipropionate

    ORBEC Amneal Pharma Europe Ltd

    NASAL FDA: approved · EMA: application withdrawn

  5. bivalirudin

    BIVALIRUDIN ARX Lacuna Pharma Pty Ltd

    INJECTION FDA: approved · EMA: withdrawn · TGA: approved

    B01AE06

  6. celecoxib

    APX-CELECOXIB Viatris Pharmaceuticals Co.,

    ORAL FDA: approved · EMA: withdrawn · TGA: approved

    L01XX33

  7. cytarabine

    PFIZER AUSTRALIA PTY LTD Pfizer Australia Pty Ltd

    INJECTION FDA: approved · EMA: withdrawn · TGA: approved · NMPA: clinical trials

    L01BC01

  8. darvadstrocel

    ALOFISEL Takeda

    EMA: withdrawn

    L04

  9. dextromethorphan hydrobromide

    NUEDEXTA Amneal Pharma Europe Ltd

    ORAL FDA: approved · EMA: withdrawn

    N07XX59

  10. diazoxide choline

    VIOKAT SOLENO THERAPEUTICS INC

    ORAL FDA: approved · EMA: application withdrawn

    N07X

  11. dinutuximab

    UNITUXIN United Therapeutics Europe Ltd

    INTRAVENOUS FDA: approved · EMA: withdrawn

    L01FX06

  12. dofetilide

    TIKOSYN Teva Pharma GmbH

    ORAL FDA: approved · EMA: withdrawn

    C01BD04

  13. eszopiclone

    LUNIVIA Teva Pharma GmbH

    ORAL FDA: approved · EMA: application withdrawn

  14. ferumoxytol

    FERAHEME Takeda

    INTRAVENOUS FDA: approved · EMA: application withdrawn

    B03AC

  15. fluocinolone acetonide

    RETISERT Amneal Pharma Europe Ltd

    TOPICAL FDA: approved · EMA: application withdrawn

  16. folic acid

    FOLTABS 500 Alphapharm Pty Ltd

    INJECTION FDA: approved · EMA: application withdrawn · TGA: approved

    V04

  17. hyaluronidase

    VITRAGAN Amphastar France Pharmaceuticals

    INJECTION FDA: approved · EMA: application withdrawn

  18. ketoprofen

    DIRACTIN Teva Pharma GmbH

    ORAL FDA: approved · EMA: application withdrawn

  19. lesinurad

    ZURAMPIC IRONWOOD PHARMACEUTICALS INC

    ORAL FDA: approved · EMA: withdrawn

    M04AB05

  20. lifileucel

    AMTAGVI Iovance Biotherapeutics B.V.

    EMA: application withdrawn

    L01XL11

  21. metformin hydrochloride

    QTRILMET Takeda

    ORAL FDA: approved · EMA: withdrawn

    A10BD

  22. mifepristone

    CORLUXIN Teva Pharma GmbH

    ORAL FDA: approved · EMA: application withdrawn

    Not yet assigned

  23. mobocertinib

    EXKIVITY Takeda

    EMA: application withdrawn

    L01EB

  24. mozafancogene autotemcel

    FANSKYA Rocket Pharmaceuticals B.V.

    EMA: application withdrawn

Frequently asked questions

How many withdrawn drugs are listed?

229 drug profiles match this regulatory segment in our published index.

Where does approval data come from?

Profiles combine FDA Drugs@FDA, EMA EPAR references, and regional authority feeds. See our data sources page for attribution.

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