Malignant Glioma

• FDA approval · 2021-11-23
  FDA Approved: TEMOZOLOMIDE — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved temozolomide from Nivagen Pharmaceuticals under an original application for the treatment of malignant gliomas, including gliob…

• FDA approval · 2020-11-20
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Temodar (temozolomide) filed by Merck Sharp & Dohme LLC, resulting in updated labeling to re…

• FDA approval · 2019-11-22
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for TEMODAR (temozolomide) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2018-12-05
  FDA Approved: GLIADEL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for GLIADEL (carmustine) submitted by Azurity Pharmaceuticals, Inc., resulting in changes to the…

• FDA approval · 2018-08-22
  FDA Approved: GLEOLAN — Supplemental Application (Medexus Pharma, Inc.)

  FDA approved a supplemental application for Gleolan (aminolevulinic acid hydrochloride) submitted by Medexus Pharma, Inc. This action consti…

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• FDA approval · 2018-06-12
  FDA Approved: GLEOLAN — Supplemental Application (Medexus Pharma, Inc.)

  FDA approved a supplemental application for Gleolan (aminolevulinic acid hydrochloride) submitted by Medexus Pharma, Inc.

• FDA approval · 2017-06-06
  FDA Approved: GLEOLAN — Original Application (Medexus Pharma, Inc.)

  The FDA approved Gleolan (aminolevulinic acid hydrochloride) from Medexus Pharma under NDA208630 for use in fluorescence-guided visualizatio…

• FDA approval · 2017-04-26
  FDA Approved: TEMOZOLOMIDE — Original Application (CivicaScript LLC)

  FDA approved Temozolomide under CivicaScript LLC's original application (ANDA207658), marking the approval of a generic Temozolomide product…

• FDA approval · 2017-02-27
  FDA Approved: TEMOZOLOMIDE — Original Application (Accord Healthcare Inc.)

  FDA approved an original application for temozolomide by Accord Healthcare Inc., authorizing a generic version of the cancer drug temozolomi…

• FDA approval · 2015-06-01
  FDA Approved: GLIADEL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for GLIADEL (carmustine) filed by Azurity Pharmaceuticals, Inc.

• FDA approval · 2015-04-02
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for TEMODAR (temozolomide) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2015-04-02
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Temodar (temozolomide) from Merck, resulting in an updated labeling and/or indication for th…

• FDA approval · 2014-11-20
  FDA Approved: GLIADEL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for GLIADEL (carmustine wafer) from Azurity Pharmaceuticals, Inc., to modify/expand its labeling…

• FDA approval · 2013-08-16
  FDA Approved: GLIADEL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for GLIADEL (carmustine) by Azurity Pharmaceuticals, Inc. The approval updates the product’s labelin…

• FDA approval · 2011-06-03
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Temodar (temozolomide) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2006-12-26
  FDA Approved: GLIADEL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for GLIADEL (carmustine) by Azurity Pharmaceuticals, Inc.