Follicular Lymphoma

• FDA approval · 2023-03-06
  FDA Approved: LENALIDOMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Lenalidomide as a generic product under an original application from Aurobindo Pharma Limited.

• 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.

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

  FDA approved Alvogen, Inc.'s original Abbreviated New Drug Application for a generic lenalidomide product (ANDA 210480).

• 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 …

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• FDA approval · 2022-12-22
  FDA Approved: LUNSUMIO — Original Application (Genentech, Inc.)

  The FDA approved Lunsumio (mosunetuzumab) from Genentech in an original application for adults with relapsed or refractory follicular lympho…

• FDA approval · 2022-12-07
  FDA Approved: VIVIMUSTA — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approved VIVIMUSTA (bendamustine hydrochloride) from Azurity Pharmaceuticals under Original Application NDA212209.

• FDA approval · 2022-12-07
  FDA Approved: BENDAMUSTINE HYDROCHLORIDE — Original Application (Apotex Corp)

  FDA approved bendamustine hydrochloride via Apotex Corp's original application, indicating the approval of a Bendamustine HCl product.

• FDA approval · 2022-09-06
  FDA Approved: LENALIDOMIDE — Original Application (EXELAN PHARMACEUTICALS INC.)

  The FDA approved Exelan Pharmaceuticals Inc.'s original application for lenalidomide, granting approval of a generic version of the cancer d…

• FDA approval · 2022-08-31
  FDA Approved: LENALIDOMIDE — Original Application (Alvogen, Inc.)

  FDA approved the original application for Lenalidomide from Alvogen, Inc., enabling a generic version of lenalidomide to enter the market.

• FDA approval · 2022-08-30
  FDA Approved: LENALIDOMIDE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved lenalidomide as an original application for Mylan Pharmaceuticals Inc., establishing a generic version of lenalidomide.

• 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 · 2022-06-03
  FDA Approved: RIABNI — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for RIABNI (rituximab-arrx) from Amgen. The action updates RIABNI’s labeling to reflect its approved…

• FDA approval · 2022-03-10
  FDA Approved: ZYDELIG — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for ZYDELIG (idelalisib) from Gilead Sciences, Inc. The action updates the labeling for the drug…

• FDA approval · 2021-12-17
  FDA Approved: COPIKTRA — Supplemental Application (Secura Bio, Inc)

  The FDA has approved a supplemental application for COPIKTRA (duvelisib) by Secura Bio, Inc.

• FDA approval · 2021-12-02
  FDA Approved: RITUXAN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Rituxan (rituximab) filed by Genentech, Inc., resulting in updated labeling for 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 · 2021-08-05
  FDA Approved: LENALIDOMIDE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for lenalidomide by Teva Pharmaceuticals, approving changes related to the drug's use.

• FDA approval · 2020-12-17
  FDA Approved: RIABNI — Original Application (Amgen, Inc)

  FDA approved RIABNI (rituximab-arrx) from Amgen as a biosimilar to rituximab via Original Application.

• FDA approval · 2020-05-05
  FDA Approved: RITUXAN HYCELA — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Rituxan HYCELA (rituximab and hyaluronidase) from Genentech, expanding its approval through …

• FDA approval · 2019-11-21
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

  The FDA approved a supplemental application for TREANDA (bendamustine hydrochloride) submitted by Cephalon, LLC.

• FDA approval · 2019-07-23
  FDA Approved: RUXIENCE — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved Ruxience (rituximab-pvvr) from Pfizer as a biosimilar to rituximab, under an original application; the approval covers multiple…

• FDA approval · 2019-05-23
  FDA Approved: TRUXIMA — Supplemental Application (Cephalon, Inc.)

  FDA approved a supplemental application for TRUXIMA (rituximab-ABBS) submitted by Cephalon, Inc.

• FDA approval · 2018-12-11
  FDA Approved: ZEVALIN — Supplemental Application (Acrotech Biopharma Inc)

  The FDA approved a supplemental application for ZEVALIN (ibritumomab tiuxetan) submitted by Acrotech Biopharma Inc.