Multiple Myeloma

• FDA approval · 2018-10-16
  FDA Approved: CARMUSTINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved the original ANDA for Carmustine (BiCNU) submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2018-09-28
  FDA Approved: KYPROLIS — Supplemental Application (Onyx Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for KYPROLIS (carfilzomib) from Onyx Pharmaceuticals, Inc., expanding its label/indication.

• FDA approval · 2018-09-11
  FDA Approved: CARMUSTINE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved Carmustine as an original ANDA for Zydus Pharmaceuticals USA Inc., authorizing a generic Carmustine formulation. The drug is us…

• FDA approval · 2018-06-29
  FDA Approved: ZOLEDRONIC ACID — Original Application (Gland Pharma Limited)

  The FDA approved an Original Application for a generic zoledronic acid product by Gland Pharma Limited.

• FDA approval · 2018-06-07
  FDA Approved: KYPROLIS — Supplemental Application (Onyx Pharmaceuticals, Inc.)

  FDA approved a supplemental application for KYPROLIS (carfilzomib) submitted by Onyx Pharmaceuticals, Inc.

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• FDA approval · 2018-01-17
  FDA Approved: KYPROLIS — Supplemental Application (Onyx Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Kyprolis (carfilzomib) submitted by Onyx Pharmaceuticals, Inc.

• FDA approval · 2017-12-29
  FDA Approved: POMALYST — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for POMALYST (pomalidomide) submitted by Celgene Corporation. The action updates the regulatory …

• FDA approval · 2017-12-22
  FDA Approved: MELPHALAN — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's original application for melphalan hydrochloride (melphalan hydrochloride) as a generic chemother…

• FDA approval · 2017-12-08
  FDA Approved: MELPHALAN HYDROCHLORIDE — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approves Dr. Reddy's Laboratories' Melphalan hydrochloride as an original generic application.

• FDA approval · 2017-12-01
  FDA Approved: MOZOBIL — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2017-11-30
  FDA Approved: POMALYST — Supplemental Application (Celgene Corporation)

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

• FDA approval · 2017-11-30
  FDA Approved: THALOMID — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for THALOMID (thalidomide) submitted by Celgene Corporation.

• FDA approval · 2017-09-25
  FDA Approved: EVOMELA — Supplemental Application (Acrotech Biopharma Inc)

  The FDA has approved a supplemental NDA for EVOMELA (liposomal melphalan) submitted by Acrotech Biopharma Inc. The approval updates the prod…

• FDA approval · 2017-06-27
  FDA Approved: POMALYST — Supplemental Application (Celgene Corporation)

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

• FDA approval · 2017-06-16
  FDA Approved: DARZALEX — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for DARZALEX (daratumumab) submitted by Janssen Biotech, Inc. to modify/expand the approved use.

• FDA approval · 2017-06-09
  FDA Approved: VELCADE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Velcade (bortezomib) filed by Takeda Pharmaceuticals America, Inc., expanding or modifying i…

• FDA approval · 2017-05-11
  FDA Approved: EMPLICITI — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for EMPLICITI (elotuzumab) submitted by E.R. Squibb & Sons, L.L.C.

• FDA approval · 2017-02-02
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for zoledronic acid submitted by Sagent Pharmaceuticals, resulting in an approved labeling change. Z…

• FDA approval · 2016-11-21
  FDA Approved: KYPROLIS — Supplemental Application (Onyx Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for KYPROLIS (carfilzomib) filed by Onyx Pharmaceuticals, Inc., marking an expanded or updated a…

• FDA approval · 2016-08-18
  FDA Approved: ZOLEDRONIC ACID — Original Application (Fresenius Kabi USA, LLC)

  FDA approved an Original Application for Zoledronic acid as a generic injectable product from Fresenius Kabi USA, LLC. The approval covers i…

• FDA approval · 2016-08-04
  FDA Approved: KYPROLIS — Supplemental Application (Onyx Pharmaceuticals, Inc.)

  FDA approved a supplemental application for KYPROLIS (carfilzomib) submitted by Onyx Pharmaceuticals, Inc. The approval updates the drug's l…

• FDA approval · 2016-07-14
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic zoledronic acid product from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals)…

• FDA approval · 2016-06-03
  FDA Approved: KYPROLIS — Supplemental Application (Onyx Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for KYPROLIS (carfilzomib) from Onyx Pharmaceuticals, Inc. This action updates the drug’s labeli…

• FDA approval · 2016-05-12
  FDA Approved: MOZOBIL — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2016-04-28
  FDA Approved: CARMUSTINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Carmustine submitted by Heritage Pharmaceuticals Inc. (doing business as Avet Pharmaceutical…