Malignant Pleural Mesothelioma

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (BluePoint Laboratories)

  The FDA approved BluePoint Laboratories' original application for a generic pemetrexed disodium product. This makes a pemetrexed disodium ge…

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (BluePoint Laboratories)

  FDA approved a generic pemetrexed disodium product (PEMETREXED) from BluePoint Laboratories under an original ANDA.

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (Sagent Pharmaceuticals)

  FDA approves an original generic application for pemetrexed disodium (Pemetrexed) by Sagent Pharmaceuticals. Pemetrexed is used in the treat…

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (BluePoint Laboratories)

  FDA approved the original application for a generic version of pemetrexed disodium (PEMETREXED) from BluePoint Laboratories.

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (Waverley Pharma Inc)

  FDA approved the original application for pemetrexed disodium (generic PEMETREXED) from Waverley Pharma Inc. This approval covers the drug's…

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• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (BluePoint Laboratories)

  FDA approved BluePoint Laboratories' Original Application for a generic pemetrexed product (PEMETREXED), authorizing its manufacture and sal…

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's original ANDA for pemetrexed disodium (generic pemetrexed), allowing marketing of a generic pemetrexe…

• FDA approval · 2020-08-21
  FDA Approved: PEMETREXED — Original Application (Teva Pharmaceuticals, Inc.)

  The FDA approved Teva Pharmaceuticals' original application for pemetrexed, a chemotherapy agent indicated for non-small cell lung cancer an…

• FDA approval · 2020-06-17
  FDA Approved: PEMFEXY — Supplemental Application (Eagle Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for PEMFEXY (pemetrexed) from Eagle Pharmaceuticals, Inc. under NDA 209472.

• FDA approval · 2020-02-08
  FDA Approved: PEMFEXY — Original Application (Eagle Pharmaceuticals, Inc.)

  FDA approved PEMFEXY (pemetrexed) from Eagle Pharmaceuticals in an Original Application, adding a pemetrexed injection option.

• FDA approval · 2018-04-17
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ALIMTA (pemetrexed disodium) from Eli Lilly and Company.

• FDA approval · 2017-08-03
  FDA Approved: GEMCITABINE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's gemcitabine injectable drug as an original application, providing a generic version of the anticancer agent…

• FDA approval · 2014-08-11
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ALIMTA (pemetrexed disodium) submitted by Eli Lilly and Company.

• FDA approval · 2013-09-12
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ALIMTA (pemetrexed disodium) submitted by Eli Lilly and Company.

• FDA approval · 2013-03-13
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ALIMTA (pemetrexed disodium) from Eli Lilly and Company, updating its labeling with addition…

• FDA approval · 2011-11-18
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ALIMTA (pemetrexed disodium) submitted by Eli Lilly and Company.

• FDA approval · 2006-07-28
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ALIMTA (pemetrexed disodium) submitted by Eli Lilly and Company.