Acute Lymphoblastic Leukemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-02-28FDA Approved: CYTARABINE — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approves Meitheal Pharmaceuticals' original application for CYTARABINE (cytarabine) as a generic injectable product, enabling its ma…
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FDA approval · 2022-02-18FDA Approved: BLINCYTO — Supplemental Application (Amgen, Inc)
The FDA approved a supplemental application for BLINCYTO (blinatumomab) submitted by Amgen, Inc.
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FDA approval · 2022-01-03FDA Approved: DASATINIB — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for dasatinib (DASATINIB) filed by Apotex Corp. The action confirms regulatory approval related to t…
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FDA approval · 2021-12-21FDA Approved: ASPARLAS — Supplemental Application (Servier Pharmaceuticals LLC)
The FDA approved a supplemental application for ASPARLAS (calaspargase pegol) from Servier Pharmaceuticals LLC, indicating an approved updat…
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FDA approval · 2021-11-23FDA Approved: DASATINIB — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s generic dasatinib (DASATINIB) under an Original Application (ANDA) for use in Philadelphia chromosome–positive l…
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FDA approval · 2021-11-02FDA Approved: ONCASPAR — Supplemental Application (Servier Pharmaceuticals LLC)
The FDA approved a supplemental application for ONCASPAR (pegaspargase) filed by Servier Pharmaceuticals LLC.
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FDA approval · 2021-10-25FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc. (ANDA089342).
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FDA approval · 2021-10-25FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc., enabling a new generic version of the drug.
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FDA approval · 2021-07-15FDA Approved: RYLAZE — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA entry describes a supplemental application for RYLAZE (asparaginase Erwinia chrysanthemi recombinant) submitted by Jazz Pharmaceutic…
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FDA approval · 2021-06-30FDA Approved: RYLAZE — Original Application (Jazz Pharmaceuticals, Inc.)
FDA approved RYLAZE (ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN) in an original application. It is indicated for the treatment of …
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FDA approval · 2021-06-29FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for dasatinib submitted by Prasco Laboratories, enabling continued or expanded marketing under a…
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FDA approval · 2021-06-14FDA Approved: TREXALL — Supplemental Application (Teva Women's Health, Inc.)
The FDA approved a supplemental application for TREXALL (methotrexate) filed by Teva Women's Health, Inc.
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FDA approval · 2021-05-19FDA Approved: CLOFARABINE — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for Clofarabine (generic) by Mylan Institutional LLC under ANDA208860.
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FDA approval · 2021-04-14FDA Approved: CLOFARABINE — Supplemental Application (Gland Pharma Limited)
FDA approved a supplemental application from Gland Pharma Limited for Clofarabine under an ANDA, authorizing its use as a generic product. T…
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FDA approval · 2021-03-25FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)
FDA approved a supplemental application for imatinib from Dr. Reddy's Laboratories, supporting an update to the drug's labeling under the AN…
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FDA approval · 2021-03-11FDA Approved: BLINCYTO — Supplemental Application (Amgen, Inc)
The FDA approved a supplemental application for BLINCYTO (blinatumomab) from Amgen, resulting in updated labeling and an expanded indication…
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FDA approval · 2021-01-29FDA Approved: MERCAPTOPURINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for mercaptopurine by Mylan Pharmaceuticals, updating the regulatory status for the marketed product…
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FDA approval · 2021-01-25FDA Approved: MERCAPTOPURINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for mercaptopurine submitted by Hikma Pharmaceuticals USA Inc., indicating changes to the product's …
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FDA approval · 2021-01-14FDA Approved: VINCRISTINE SULFATE — Supplemental Application (Hospira, Inc.)
The FDA approved a supplemental application filed by Hospira for vincristine sulfate, a generic vincristine product.
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FDA approval · 2020-10-23FDA Approved: CLOFARABINE — Original Application (Meitheal Pharmaceuticals Inc.)
FDA approved a generic clofarabine product (Clofarabine) from Meitheal Pharmaceuticals Inc. under an original application. It is indicated f…
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FDA approval · 2020-08-10FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for GLEEVEC (imatinib mesylate) from Novartis, approving changes to the product labeling based o…
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FDA approval · 2020-07-23FDA Approved: IMATINIB MESYLATE — Original Application (BluePoint Laboratories)
FDA approved imatinib mesylate as an original-application generic drug for BluePoint Laboratories.
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FDA approval · 2020-07-10FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, Inc., approving changes t…
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FDA approval · 2020-06-26FDA Approved: CYTARABINE — Original Application (Meitheal Pharmaceuticals Inc.)
FDA approval of Meitheal Pharmaceuticals' original ANDA for Cytarabine (cytarabine), a generic injectable anticancer agent.
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FDA approval · 2020-06-24FDA Approved: ASPARLAS — Supplemental Application (Servier Pharmaceuticals LLC)
FDA approved a supplemental application for ASPARLAS (calaspargase pegol) from Servier Pharmaceuticals LLC, resulting in a labeling update. …