Marginal Zone Lymphoma

• FDA approval · 2025-01-31
  FDA Approved: LENALIDOMIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's generic lenalidomide (LENALIDOMIDE) under an Original Application (ANDA 216213).

• FDA approval · 2024-09-11
  FDA Approved: LENALIDOMIDE — Original Application (Novugen Pharma (USA) LLC)

  FDA approved the original application for lenalidomide from Novugen Pharma (USA) LLC, enabling a generic version of the cancer drug lenalido…

• FDA approval · 2024-02-08
  FDA Approved: VIVIMUSTA — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for VIVIMUSTA (bendamustine hydrochloride) filed by Azurity Pharmaceuticals, Inc., to update/exp…

• FDA approval · 2023-03-24
  FDA Approved: LENALIDOMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for lenalidomide submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2023-03-06
  FDA Approved: LENALIDOMIDE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved a generic lenalidomide product for Teva under ANDA201452, expanding access to lenalidomide formulations.

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• FDA approval · 2023-03-06
  FDA Approved: LENALIDOMIDE — Original Application (EXELAN PHARMACEUTICALS INC.)

  FDA approves a generic lenalidomide product from Exelan Pharmaceuticals under an original application. The drug is indicated for several hem…

• FDA approval · 2023-02-08
  FDA Approved: LENALIDOMIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' Lenalidomide Original Application, granting a generic lenalidomide product for multiple myeloma …

• FDA approval · 2022-07-06
  FDA Approved: ZYDELIG — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for ZYDELIG (idelalisib) submitted by Gilead Sciences, Inc. The specific changes to the product'…

• FDA approval · 2021-10-14
  FDA Approved: LENALIDOMIDE — Original Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved Dr. Reddy's Laboratories' original application for lenalidomide (generic), authorizing a generic version of the cancer drug…

• FDA approval · 2021-08-31
  FDA Approved: REVLIMID — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for REVLIMID (lenalidomide) submitted by Celgene Corporation. The action expands or updates the …

• FDA approval · 2020-04-21
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approved a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC.

• FDA approval · 2018-02-06
  FDA Approved: ZYDELIG — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for ZYDELIG (idelalisib) filed by Gilead Sciences, Inc.