Anaplastic Astrocytoma

• EMA approval · 2025-11-06
  EMA Authorised: Temodal (temozolomide) — Merck Sharp & Dohme B.V.

  The EMA authorised Temodal (temozolomide) for glioma, with Merck Sharp & Dohme B.V. as the marketing authorisation holder; decision date 06/…

• FDA approval · 2025-10-27
  FDA Approved: LOMUSTINE — Original Application (Carnegie Pharmaceuticals LLC)

  FDA approves Carnegie Pharmaceuticals LLC's original application for lomustine (LOMUSTINE), making a generic version of the chemotherapy dru…

• FDA approval · 2024-08-23
  FDA Approved: TEMOZOLOMIDE — Supplemental Application (CivicaScript LLC)

  FDA approved CivicaScript LLC's supplemental application for temozolomide, a generic version of the chemotherapy drug Temozolomide (ANDA 207…

• FDA approval · 2024-08-23
  FDA Approved: TEMOZOLOMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic temozolomide through an original application for the treatment of malignant gliomas, including …

• FDA approval · 2022-08-03
  FDA Approved: TEMOZOLOMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approves a supplemental application for Temozolomide from Accord Healthcare Inc., a generic cancer drug.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2020-08-13
  FDA Approved: TEMOZOLOMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approves Accord Healthcare Inc.'s supplemental application for temozolomide, supporting a generic version of the drug. The action corres…

• 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 · 2019-07-16
  FDA Approved: TEMOZOLOMIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's supplemental application for temozolomide, a generic version of Temodar, under ANDA 203691.

• 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 · 2017-02-24
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Temodar (temozolomide) filed by Merck Sharp & Dohme LLC. The action updates Temodar's labeling t…

• FDA approval · 2016-04-28
  FDA Approved: CARMUSTINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Carmustine submitted by Heritage Pharmaceuticals Inc. (doing business as Avet Pharmaceutical…

• FDA approval · 2016-04-27
  FDA Approved: TEMOZOLOMIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for temozolomide in a generic form, enabling Rising Pharma Holdings, Inc. to market temozolomide.

• FDA approval · 2015-09-18
  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 · 2015-09-18
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for TEMODAR (temozolomide) submitted by Merck Sharp & Dohme LLC. The action updates the drug's label…

• FDA approval · 2015-06-10
  FDA Approved: TEMOZOLOMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for temozolomide from Sun Pharmaceutical Industries, Inc., under ANDA201742, granting a supplemental…

• FDA approval · 2015-05-08
  FDA Approved: TEMOZOLOMIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's Original Application for temozolomide (generic temozolomide), authorizing its marketed generic pro…

• 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 · 2015-01-05
  FDA Approved: TEMOZOLOMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' supplemental application to authorize a generic version of temozolomide.

• FDA approval · 2014-03-20
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2014-02-12
  FDA Approved: TEMOZOLOMIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a generic temozolomide product under an original ANDA from Sun Pharmaceutical Industries, Inc. Temozolomide is used to treat ma…

• FDA approval · 2013-08-15
  FDA Approved: GLEOSTINE — Supplemental Application (NextSource Biotechnology, LLC)

  The FDA approved a supplemental application for Gleostine (lomustine) submitted by NextSource Biotechnology, LLC.