Alzheimer Disease

• FDA label_change · 2020-04-24
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for memantine hydrochloride filed by Unichem Pharmaceuticals (USA), Inc., updating the product label…

• FDA label_change · 2015-11-30
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for donepezil hydrochloride filed by Rising Pharma Holdings, Inc., likely reflecting labeling ch…

• FDA label_change · 2015-05-04
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  FDA approved a supplemental application for NEURACEQ (Florbetaben F-18) by Lantheus Biosciences Ltd., expanding its labeling.

• FDA label_change · 2014-10-15
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  The FDA approved a supplemental application for NEURACEQ (florbetaben F-18), expanding labeling to support its use as a PET imaging agent to…

• FDA label_change · 2014-03-14
  FDA Approved: AMYVID — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for AMYVID (Florbetapir F-18) by Eli Lilly, updating the labeling for its use as an amyloid imaging …

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• FDA label_change · 2013-04-04
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

  FDA notice of a supplemental application for ARICEPT (donepezil hydrochloride) submitted by Eisai Inc., indicating an update to the product …