Alzheimer Disease

• FDA approval · 2013-07-25
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for donepezil hydrochloride from Rising Pharma Holdings, Inc., related to an approved product (speci…

• FDA approval · 2013-07-24
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Dr. Reddys Laboratories Limited)

  FDA approved the original application for a generic donepezil hydrochloride product from Dr. Reddy's Laboratories Limited, enabling a generi…

• FDA approval · 2013-06-27
  FDA Approved: RIVASTIGMINE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for rivastigmine submitted by Sandoz Inc.

• FDA approval · 2013-03-27
  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. The submission status indicates approv…

• FDA approval · 2013-03-22
  FDA Approved: AMYVID — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for AMYVID (florbetapir F-18) from Eli Lilly and Company. This action updates the labeling and may e…

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• FDA approval · 2013-03-13
  FDA Approved: RIVASTIGMINE — Supplemental Application (Sandoz Inc)

  FDA approves a supplemental application for rivastigmine submitted by Sandoz Inc.

• FDA approval · 2013-03-13
  FDA Approved: AMYVID — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for AMYVID (Florbetapir F-18) from Eli Lilly, advancing its regulatory status for use in evaluating …

• FDA approval · 2013-03-11
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for memantine hydrochloride (Actavis Pharma, Inc.), resulting in updated labeling for the produc…

• EMA approval · 2013-03-11
  EMA Refused: Balaxur (memantine hydrochloride;donepezil hydrochloride) — Merz Pharmaceuticals GmbH

  EMA decision to refuse Balaxur (memantine hydrochloride; donepezil hydrochloride) for Alzheimer’s disease.

• FDA approval · 2013-03-06
  FDA Approved: AMYVID — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for AMYVID (florbetapir F-18) from Eli Lilly and Company.

• FDA approval · 2013-02-25
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals Inc.'s original application for donepezil hydrochloride, a generic version of the Alzheimer's disease t…

• FDA approval · 2013-02-19
  FDA Approved: AMYVID — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for AMYVID (florbetapir F-18) from Eli Lilly and Company. The notice indicates the agency completed …

• FDA approval · 2013-01-18
  FDA Approved: AMYVID — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for AMYVID (florbetapir F-18) from Eli Lilly, updating its labeling. The imaging agent is intended t…

• FDA approval · 2013-01-07
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Dr. Reddys Laboratories Limited)

  FDA approved a supplemental application for donepezil hydrochloride submitted by Dr. Reddys Laboratories Limited.

• FDA approval · 2012-12-14
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves Macleods Pharmaceuticals Limited's generic donepezil hydrochloride tablets under ANDA 201787 for the treatment of symptoms of A…

• EMA approval · 2012-10-19
  European Medicines Agency recommends approval of first radiopharmaceutical for PET imaging of β-amyloid neuritic plaque density

  EMA recommends approval of the first radiopharmaceutical for PET imaging of beta-amyloid neuritic plaque density, enabling visualization of …

• FDA approval · 2012-10-12
  FDA Approved: GALANTAMINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for galantamine from Aurobindo Pharma Limited under an ANDA, authorizing changes to the approved…

• FDA approval · 2012-09-04
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for ARICEPT (donepezil hydrochloride) submitted by Eisai Inc., resulting in changes to the product's…

• FDA approval · 2012-09-04
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for Aricept (donepezil hydrochloride) from Eisai Inc.

• FDA approval · 2012-08-31
  FDA Approved: RIVASTIGMINE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for rivastigmine submitted by Sandoz Inc.

• FDA approval · 2012-08-17
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves a generic donepezil hydrochloride product for Alzheimer's disease under an Original Application (ANDA). The applicant is Macleo…

• FDA approval · 2012-06-12
  FDA Approved: RIVASTIGMINE TARTRATE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original application for rivastigmine tartrate as a generic drug. This approval enables a gen…

• FDA approval · 2012-04-06
  FDA Approved: AMYVID — Original Application (Eli Lilly and Company)

  FDA approved AMYVID (florbetapir F-18) in an original application from Eli Lilly and Company, establishing its use as a PET imaging agent fo…

• FDA approval · 2012-04-06
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved Solco Healthcare US, LLC's supplemental application to market a generic donepezil hydrochloride product for Alzheimer's dis…

• FDA approval · 2012-03-07
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for Aricept (donepezil hydrochloride) from Eisai Inc.