Alzheimer Disease

• FDA approval · 2024-07-02
  FDA Approved: KISUNLA — Original Application (Eli Lilly and Company)

  FDA approved Kisunla (donanemab-azbt) from Eli Lilly in an original Biologics License Application for adults with early Alzheimer's disease …

• FDA approval · 2024-05-17
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Carlsbad Technology, Inc.)

  The FDA approved a supplemental application for memantine hydrochloride from Carlsbad Technology, Inc., approving changes to the approved ge…

• FDA approval · 2024-05-08
  FDA Approved: RIVASTIGMINE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for rivastigmine filed by Sandoz Inc, resulting in an approved modification to the existing rivastig…

• FDA approval · 2024-02-06
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Vitruvias Therapeutics, Inc.)

  FDA approved a supplemental application for MEMANTINE HYDROCHLORIDE by Vitruvias Therapeutics, Inc., confirming approval for this generic me…

• FDA approval · 2024-02-05
  FDA Approved: TAUVID — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Tauvid (flortaucipir F-18) enabling its use for PET imaging of tau neurofibrillary tangles in ad…

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• EMA approval · 2024-01-17
  EMA Authorised: Nemdatine (memantine) — Actavis Group PTC ehf

  EMA authorised Nemdatine (memantine) for Alzheimer disease; marketed by Actavis Group PTC ehf. Decision date 16/01/2024.

• FDA approval · 2023-12-15
  FDA Approved: MEMANTINE AND DONEPEZIL HYDROCHLORIDES — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved a generic fixed-dose combination of memantine hydrochloride and donepezil hydrochloride (Memantine and Donepezil Hydrochlorides…

• FDA approval · 2023-12-08
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (ACI Healthcare USA, Inc.)

  FDA approved a supplemental application for donepezil hydrochloride submitted by ACI Healthcare USA, Inc.

• FDA approval · 2023-11-02
  FDA Approved: GALANTAMINE HYDROBROMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for GALANTAMINE HYDROBROMIDE from Hikma Pharmaceuticals USA Inc., approving the generic product.

• FDA approval · 2023-10-31
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  The FDA approved a supplemental application for NEURACEQ (florbetaben F-18) to expand its labeling for PET imaging to estimate beta-amyloid …

• FDA approval · 2023-07-06
  FDA Approved: LEQEMBI — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for LEQEMBI (lecanemab) from Eisai Inc., indicating a regulatory action related to the product.

• FDA approval · 2023-06-28
  FDA Approved: GALANTAMINE — Supplemental Application (Slate Run Pharmaceuticals, LLC)

  FDA approved a supplemental application for GALANTAMINE from Slate Run Pharmaceuticals, LLC.

• FDA approval · 2023-06-07
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for donepezil hydrochloride from Macleods Pharmaceuticals Limited, enabling a regulatory change …

• FDA approval · 2023-06-07
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for donepezil hydrochloride (generic) from Macleods Pharmaceuticals Limited.

• FDA approval · 2023-06-07
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for memantine hydrochloride by Macleods Pharmaceuticals Limited, updating the approved drug prod…

• FDA approval · 2023-02-02
  FDA Approved: GALANTAMINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for galantamine submitted by Aurobindo Pharma Limited.

• FDA approval · 2023-01-18
  FDA Approved: GALANTAMINE HYDROBROMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for galantamine hydrobromide from Sun Pharmaceutical Industries, Inc., under an ANDA.

• FDA approval · 2023-01-17
  FDA Approved: GALANTAMINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for galantamine from Aurobindo Pharma Limited. This action pertains to a generic product used to tre…

• FDA approval · 2023-01-06
  FDA Approved: LEQEMBI — Original Application (Eisai Inc.)

  FDA approved LEQEMBI (lecanemab) in an original BLA submission from Eisai Inc. for the treatment of Alzheimer's disease.

• FDA approval · 2022-10-11
  FDA Approved: MEMANTINE HYDROCHLORIDE — Original Application (Vitruvias Therapeutics, Inc.)

  FDA approved a generic memantine hydrochloride product under an Original Application (ANDA) from Vitruvias Therapeutics, Inc. for the treatm…

• FDA approval · 2022-09-26
  FDA Approved: MEMANTINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a generic memantine hydrochloride product from Camber Pharmaceuticals under its Original Application, intended for treating…

• FDA approval · 2022-08-19
  FDA Approved: AMYVID — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for AMYVID (florbetapir F-18) from Eli Lilly and Company, an imaging agent used to assess beta-a…

• FDA approval · 2022-07-01
  FDA Approved: TAUVID — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for TAUVID (flortaucipir F-18) from Eli Lilly, updating its labeling and/or indication. TAUVID is a …

• EMA approval · 2022-06-30
  EMA Authorised: Memantine ratiopharm (memantine hydrochloride) — Ratiopharm GmbH

  Memantine ratiopharm has been authorised for use in its indicated therapeutic area.

• FDA approval · 2022-06-08
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  The FDA granted a supplemental approval for NEURACEQ (florbetaben F-18), a PET imaging agent. The approval expands its use for evaluating be…