Non-small Cell Lung Cancer

• EMA approval · 2023-01-19
  EMA Authorised: Pemetrexed Baxter (pemetrexed disodium heptahydrate) — Baxter Holding B.V.

  The EMA authorised Pemetrexed Baxter (pemetrexed disodium heptahydrate) for non-small cell lung carcinoma and mesothelioma.

• FDA approval · 2022-12-14
  FDA Approved: PEMFEXY — Supplemental Application (Eagle Pharmaceuticals, Inc.)

  FDA approved a supplemental application for PEMFEXY (pemetrexed) from Eagle Pharmaceuticals.

• FDA approval · 2022-12-13
  FDA Approved: PEMETREXED — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved the original application for pemetrexed disodium from Meitheal Pharmaceuticals Inc., a generic version of the cancer drug pemet…

• FDA approval · 2022-12-12
  FDA Approved: KRAZATI — Original Application (Mirati Therapeutics, Inc)

  The FDA approves KRAZATI (adagrasib) from Mirati Therapeutics under the original NDA for metastatic KRAS G12C-mutant non-small cell lung can…

• FDA approval · 2022-11-22
  FDA Approved: DOCIVYX — Original Application (Avyxa Pharma, LLC)

  FDA approves DOCIVYX (docetaxel) under an original NDA submitted by Avyxa Pharma, LLC.

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• FDA approval · 2022-11-22
  FDA Approved: PEMETREXED — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for pemetrexed filed by Teva Pharmaceuticals, Inc., expanding the drug's labeled uses.

• FDA approval · 2022-10-20
  FDA Approved: PACLITAXEL — Original Application (BluePoint Laboratories)

  FDA approves paclitaxel as a generic product under an original application from BluePoint Laboratories.

• FDA approval · 2022-09-30
  FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for TAGRISSO (osimertinib) submitted by AstraZeneca Pharmaceuticals LP. This action constitutes regu…

• FDA approval · 2022-08-10
  FDA Approved: TABRECTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tabrecta (capmatinib) from Novartis Pharmaceuticals Corporation, authorizing changes to its …

• FDA approval · 2022-07-27
  FDA Approved: PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND — Original Application (American Regent, Inc.)

  FDA approved paclitaxel protein-bound particles albumin-bound (paclitaxel) from American Regent, Inc. under an Original Application (NDA2118…

• FDA approval · 2022-06-22
  FDA Approved: PEMETREXED — Original Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s original application for pemetrexed (injectable), authorizing a generic pemetrexed product with the established…

• FDA approval · 2022-06-22
  FDA Approved: ERLOTINIB — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic erlotinib product. Erlotinib is used to treat certain cancers…

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (Zydus Lifesciences Limited)

  The FDA approved a generic pemetrexed disodium product (PEMETREXED DISODIUM) from Zydus Lifesciences Limited.

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED DISODIUM — Original Application (Dr. Reddys Laboratories Inc)

  FDA approval of a generic pemetrexed disodium product (ANDA) submitted by Dr. Reddy's Laboratories Inc.

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s original application for a generic pemetrexed product.

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

  FDA approved Meitheal Pharmaceuticals' original application for pemetrexed disodium, a generic version of pemetrexed for cancer indications.

• 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…

• 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 · 2022-04-13
  FDA Approved: ALYMSYS — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves ALYMSYS as a biosimilar to bevacizumab (bevaczizumab-maly) from Amneal Pharmaceuticals LLC under an original Biologics License …

• FDA approval · 2022-02-28
  FDA Approved: ALUNBRIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ALUNBRIG (brigatinib) submitted by Takeda Pharmaceuticals America, Inc.