Alzheimer Disease

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

  FDA approved a supplemental application for ARICEPT (donepezil hydrochloride) submitted by Eisai Inc. This action provides an additional app…

• FDA approval · 2011-05-31
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (ACI Healthcare USA, Inc.)

  FDA approved a generic donepezil hydrochloride product under an original application, intended for the treatment of Alzheimer's disease.

• FDA approval · 2011-05-31
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Solco Healthcare US, LLC)

  FDA approved Solco Healthcare US, LLC's original application for donepezil hydrochloride (generic) tablets. This approval enables use of the…

• FDA approval · 2011-05-31
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Dr. Reddys Laboratories Limited)

  FDA approved the generic donepezil hydrochloride from Dr. Reddys Laboratories Limited via an Original Application for treating Alzheimer's d…

• FDA approval · 2011-05-31
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original ANDA for donepezil hydrochloride (generic) from Rising Pharma Holdings, Inc., expanding access to a generic treatm…

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• FDA approval · 2011-05-31
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's donepezil hydrochloride as an original generic application, enabling a generic treatment opti…

• FDA approval · 2011-03-29
  FDA Approved: GALANTAMINE — Original Application (Aurobindo Pharma Limited)

  FDA approves the Original Application (ANDA) for Galantamine submitted by Aurobindo Pharma Limited.

• FDA approval · 2011-02-02
  FDA Approved: GALANTAMINE HYDROBROMIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' original ANDA for galantamine hydrobromide, a generic version of galantamine indicated for mild …

• FDA approval · 2010-12-02
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for ARICEPT (donepezil hydrochloride) filed by Eisai Inc.

• FDA approval · 2010-12-02
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

  The FDA approved Eisai Inc.'s supplemental application for ARICEPT (donepezil hydrochloride), resulting in an update to the product labeling…

• FDA approval · 2010-08-27
  FDA Approved: RIVASTIGMINE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for rivastigmine submitted by Sandoz Inc under NDA022083.

• FDA approval · 2010-07-23
  FDA Approved: ARICEPT — Original Application (Eisai Inc.)

  FDA approved ARICEPT (donepezil hydrochloride) under an original application by Eisai Inc. for the treatment of Alzheimer's disease. The ent…

• FDA approval · 2010-05-05
  FDA Approved: MEMANTINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's memantine hydrochloride generic under an original application.

• FDA approval · 2010-04-14
  FDA Approved: MEMANTINE — Original Application (NorthStar RxLLC)

  The FDA approved the original application for memantine as a generic product, manufactured by NorthStar RxLLC. This marks the availability o…

• FDA approval · 2009-02-06
  FDA Approved: GALANTAMINE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved an original Abbreviated New Drug Application (ANDA) for galantamine from Slate Run Pharmaceuticals, LLC.

• FDA approval · 2007-10-31
  FDA Approved: RIVASTIGMINE TARTRATE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' rivastigmine tartrate as an original-application generic (ANDA) product. It is indicated for the trea…

• FDA approval · 2007-10-22
  FDA Approved: RIVASTIGMINE TARTRATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a generic rivastigmine tartrate product from Sun Pharmaceutical Industries under an original ANDA, for the same indications as …

• FDA approval · 2007-07-06
  FDA Approved: RIVASTIGMINE — Original Application (Sandoz Inc)

  FDA approved rivastigmine under an original application from Sandoz Inc, marking the approval of a rivastigmine generic product.

• FDA approval · 2006-12-21
  FDA Approved: FLUDEOXYGLUCOSE F18 — Supplemental Application (THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH)

  FDA approved a supplemental application for Fludeoxyglucose F18, a PET imaging radiopharmaceutical, expanding its regulatory status.

• FDA approval · 2006-10-13
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

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

• FDA approval · 2006-10-04
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for memantine hydrochloride by Actavis Pharma, Inc., resulting in an approved update to the product'…

• FDA approval ·
  FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

  FDA approves Auvelity as the first non-antipsychotic drug to treat agitation associated with dementia due to Alzheimer’s disease in adults.