Invasive Candidiasis

• FDA approval · 2019-07-16
  FDA Approved: FLUCONAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Fluconazole from Zydus Lifesciences Limited, resulting in regulatory approval of this generic pr…

• FDA approval · 2019-05-17
  FDA Approved: MICAFUNGIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's original ANDA for micafungin sodium (Micafungin), a generic echinocandin antifungal. The approval cov…

• FDA approval · 2018-03-13
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for Cancidas (caspofungin acetate) to update labeling and/or expand its indications, as part of Merc…

• FDA approval · 2018-01-05
  FDA Approved: ERAXIS — Supplemental Application (Roerig)

  FDA approved a supplemental application for ERAXIS (anidulafungin) submitted by Roerig to update/expand the product labeling.

• FDA approval · 2017-07-07
  FDA Approved: FLUCYTOSINE — Original Application (Lupin Pharmaceuticals,Inc.)

  The FDA approved Lupin Pharmaceuticals' original application for Flucytosine (generic) to market the drug in the United States.

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• FDA approval · 2016-12-30
  FDA Approved: CASPOFUNGIN ACETATE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved caspofungin acetate for the treatment of invasive candidiasis (including candidemia) and esophageal candidiasis.

• FDA approval · 2014-10-23
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for CANCIDAS (caspofungin acetate) filed by Merck Sharp & Dohme LLC.

• FDA approval · 2014-03-28
  FDA Approved: ERAXIS — Supplemental Application (Roerig)

  FDA's supplemental application for ERAXIS (anidulafungin) submitted by Roerig is noted as a supplemental approval action. The entry shows th…

• FDA approval · 2013-12-18
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for CANCIDAS (caspofungin acetate) from Merck Sharp & Dohme LLC to update its labeling.

• FDA approval · 2013-11-25
  FDA Approved: NOXAFIL — Original Application (Merck Sharp & Dohme LLC)

  FDA approves NOXAFIL (posaconazole) through Merck's original NDA. The approval recognizes posaconazole for prevention and treatment of invas…

• FDA approval · 2013-01-08
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for CANCIDAS (caspofungin acetate) from Merck Sharp & Dohme LLC, authorizing changes to the drug's l…

• FDA approval · 2012-01-30
  FDA Approved: FLUCONAZOLE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s generic fluconazole under Original Application (ANDA 078698). The approval covers multiple fun…

• FDA approval · 2011-10-13
  FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for fluconazole by Rising Pharma Holdings, Inc., authorizing an updated generic product under the AN…

• FDA approval · 2011-06-08
  FDA Approved: MYCAMINE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for MYCAMINE (micafungin sodium) from Astellas Pharma US, Inc., updating its labeling with indicatio…

• FDA approval · 2009-05-04
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Cancidas (caspofungin acetate) to expand its labeling.

• FDA approval · 2007-08-06
  FDA Approved: MYCAMINE — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for MYCAMINE (micafungin sodium) by Astellas Pharma US, Inc.

• FDA approval · 2006-08-07
  FDA Approved: ERAXIS — Supplemental Application (Roerig)

  The FDA approved a supplemental application for ERAXIS (anidulafungin) submitted by Roerig.

• FDA approval · 2006-06-27
  FDA Approved: MYCAMINE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for MYCAMINE (micafungin sodium) from Astellas Pharma US, Inc., expanding labeling through a supplem…