Alzheimer Disease

• FDA approval · 2019-04-16
  FDA Approved: RIVASTIGMINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for rivastigmine from Mylan Pharmaceuticals Inc. under ANDA 205622, updating the generic product's a…

• FDA approval · 2019-04-04
  FDA Approved: RIVASTIGMINE TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application from Aurobindo Pharma Limited for rivastigmine tartrate (generic), authorizing its use for treat…

• FDA approval · 2019-03-21
  FDA Approved: RIVASTIGMINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for rivastigmine by Amneal Pharmaceuticals LLC under ANDA207308.

• FDA approval · 2019-03-04
  FDA Approved: RIVASTIGMINE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the original generic application for rivastigmine from Zydus Pharmaceuticals USA Inc., enabling the marketing of rivastigmine p…

• FDA approval · 2019-01-08
  FDA Approved: RIVASTIGMINE — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals' generic rivastigmine via Original Application (ANDA). The product is indicated for the treatment of…

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• FDA approval · 2018-12-18
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for ARICEPT (donepezil hydrochloride) submitted by Eisai Inc., updating the product labeling.

• FDA approval · 2018-12-18
  FDA Approved: RIVASTIGMINE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for rivastigmine submitted by Sandoz Inc. This action updates rivastigmine's regulatory status t…

• FDA approval · 2018-12-18
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

  The FDA approved a supplemental application for ARICEPT (donepezil hydrochloride) by Eisai Inc. This action updates the product's labeling p…

• FDA approval · 2018-11-02
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for memantine hydrochloride (Actavis Pharma, Inc.) under NDA 021487. This action updates the approve…

• FDA approval · 2018-07-27
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Hisun Pharmaceuticals USA, Inc.)

  FDA approved a generic version of donepezil hydrochloride for the treatment of symptoms of Alzheimer's disease under ANDA 205269 for Hisun P…

• FDA approval · 2018-07-17
  FDA Approved: GALANTAMINE HYDROBROMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Hikma's galantamine hydrobromide, authorizing its marketing as a generic product for Alzheimer's…

• FDA approval · 2018-07-11
  FDA Approved: MEMANTINE — Original Application (Chartwell RX, LLC)

  FDA approved the original ANDA for memantine as a generic drug manufactured by Chartwell RX, LLC.

• FDA approval · 2018-07-10
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  FDA approved a supplemental application for NEURACEQ (Florbetaben F-18) from Lantheus Biosciences Ltd.

• FDA approval · 2018-06-20
  FDA Approved: RIVASTIGMINE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved an original generic rivastigmine application from Mylan for treatment of dementia associated with Alzheimer's disease and Parki…

• FDA approval · 2018-03-06
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for Memantine hydrochloride (Macleods Pharmaceuticals Limited).

• FDA approval · 2018-02-09
  FDA Approved: MEMANTINE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original application for memantine hydrochloride, a generic memantine, for the treatment of Alzheimer's disease.

• FDA approval · 2017-12-27
  FDA Approved: GALANTAMINE — Supplemental Application (Slate Run Pharmaceuticals, LLC)

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

• FDA approval · 2017-12-14
  FDA Approved: GALANTAMINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Galantamine from Aurobindo Pharma Limited, authorizing the generic version for use in mild to mo…

• FDA approval · 2017-09-28
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Torrent Pharmaceuticals Limited to market donepezil hydrochloride as a generic product for the t…

• FDA approval · 2017-09-28
  FDA Approved: RIVASTIGMINE TARTRATE — Original Application (Chartwell RX, LLC)

  FDA approves the original application for rivastigmine tartrate (generic) manufactured by Chartwell RX, LLC.

• FDA approval · 2017-09-19
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Cadila Pharmaceuticals Limited)

  FDA approves Cadila Pharmaceuticals' original application for a generic donepezil hydrochloride product for the treatment of Alzheimer's dis…

• FDA approval · 2017-08-03
  FDA Approved: MEMANTINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved memantine hydrochloride as an original generic application by Zydus Lifesciences Limited. The approval covers memantine hydroch…

• FDA approval · 2017-07-10
  FDA Approved: MEMANTINE HYDROCHLORIDE — Original Application (Viona Pharmaceuticals Inc)

  FDA approved an original application for memantine hydrochloride from Viona Pharmaceuticals Inc, establishing a generic version indicated fo…

• FDA approval · 2017-06-16
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  FDA approved a supplemental application for NEURACEQ (Florbetaben F-18) submitted by Lantheus Biosciences Ltd. The action expands the regula…

• FDA approval · 2017-02-22
  FDA Approved: VIZAMYL — Supplemental Application (GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare))

  FDA approved a supplemental application for Vizamyl (flutemetamol F-18) submitted by GE Healthcare Inc. The action updates the regulatory st…