Multiple Myeloma

• FDA approval · 2013-11-15
  FDA Approved: POMALYST — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for POMALYST (pomalidomide) by Celgene Corporation, expanding its approved use. This confirms regula…

• FDA approval · 2013-10-03
  FDA Approved: POMALYST — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for POMALYST (pomalidomide) submitted by Celgene Corporation.

• FDA approval · 2013-09-23
  FDA Approved: ZOLEDRONIC ACID — Original Application (Sagent Pharmaceuticals)

  FDA approves a generic zoledronic acid injection from Sagent Pharmaceuticals under ANDA 202828, granting approval to market the product for …

• FDA approval · 2013-06-17
  FDA Approved: CYCLOPHOSPHAMIDE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for cyclophosphamide from Civica, Inc. under ANDA 040745.

• FDA approval · 2013-06-04
  FDA Approved: MOZOBIL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for MOZOBIL (plerixafor) submitted by Sanofi-Aventis U.S. LLC.

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• FDA approval · 2013-06-03
  FDA Approved: ZOLEDRONIC ACID — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s original application for a generic zoledronic acid injectable product.

• EMA approval · 2013-05-31
  European Medicines Agency recommends approval of pomalidomide for the treatment of multiple myeloma

  The EMA recommends approving pomalidomide for the treatment of multiple myeloma, indicating a potential new therapy option for this disease.

• FDA approval · 2013-03-29
  FDA Approved: ZOLEDRONIC ACID — Original Application (Dr.Reddy's Laboratories Ltd)

  FDA approved the original application for Zoledronic acid (generic) from Dr. Reddy's Laboratories Ltd. This approval confirms a generic vers…

• FDA approval · 2013-03-04
  FDA Approved: ZOLEDRONIC ACID — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's zoledronic acid under an original application, enabling a generic version of the drug.

• FDA approval · 2013-02-26
  FDA Approved: MOZOBIL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Mozobil (plerixafor) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2013-02-08
  FDA Approved: POMALYST — Original Application (Celgene Corporation)

  FDA approved POMALYST (pomalidomide) from Celgene as the original application for the treatment of multiple myeloma.

• FDA approval · 2012-07-20
  FDA Approved: KYPROLIS — Original Application (Onyx Pharmaceuticals, Inc.)

  The FDA approved KYPROLIS (carfilzomib) in its original application for the treatment of multiple myeloma in patients who have received at l…

• FDA approval · 2011-12-21
  FDA Approved: REVLIMID — Supplemental Application (Celgene Corporation)

  The FDA approves a supplemental application for Revlimid (lenalidomide) submitted by Celgene Corporation, updating regulatory status for the…

• FDA approval · 2011-07-14
  FDA Approved: MELPHALAN HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for Melphalan Hydrochloride from Mylan Institutional LLC, authorizing the generic drug's continued m…

• FDA approval · 2011-01-25
  FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for RECLAST (zoledronic acid) filed by Sandoz Inc.

• FDA approval · 2010-10-12
  FDA Approved: REVLIMID — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for REVLIMID (lenalidomide) submitted by Celgene Corporation.

• FDA approval · 2010-02-26
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

  The FDA approved a supplemental application for TREANDA (bendamustine hydrochloride) from Cephalon, LLC, enabling revisions to its labeling …

• FDA approval · 2008-12-15
  FDA Approved: MOZOBIL — Original Application (Sanofi-Aventis U.S. LLC)

  FDA approved Mozobil (plerixafor) under an Original Application (NDA022311) to mobilize hematopoietic stem cells in combination with G-CSF f…

• FDA approval · 2008-06-20
  FDA Approved: VELCADE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Velcade (bortezomib) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2006-05-31
  FDA Approved: VELCADE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Velcade (bortezomib) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval ·
  FDA Grants Third Approval Under the National Priority Voucher Program

  FDA-approved teclistamab in combination with daratumumab hyaluronidase-fihj (Tec-Dara) for adults with relapsed or refractory multiple myelo…