Alzheimer Disease

• FDA approval · 2015-04-10
  FDA Approved: MEMANTINE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for memantine hydrochloride, a generic version of memantine.

• FDA approval · 2015-02-03
  FDA Approved: RIVASTIGMINE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for rivastigmine filed by Sandoz Inc.

• FDA approval · 2015-02-03
  FDA Approved: VIZAMYL — Supplemental Application (GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare))

  FDA approved a supplemental application for Vizamyl (flutemetamol F-18) from GE Healthcare, indicating regulatory approval of a supplemental…

• FDA approval · 2015-01-30
  FDA Approved: DONEPEZIL — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved the original application for donepezil hydrochloride (generic) by Quallent Pharmaceuticals Health LLC, extending its availabili…

• FDA approval · 2014-12-23
  FDA Approved: NAMZARIC — Original Application (Allergan, Inc.)

  FDA approved NAMZARIC, a fixed-dose combination of memantine hydrochloride and donepezil hydrochloride, under an original application from A…

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• FDA approval · 2014-12-04
  FDA Approved: VIZAMYL — Supplemental Application (GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare))

  The FDA approved a supplemental application for Vizamyl (flutemetamol F-18) by GE Healthcare.

• FDA approval · 2014-10-29
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith Laboratories' generic donepezil hydrochloride product through an original application. The product is intended…

• FDA approval · 2014-10-29
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved ScieGen Pharmaceuticals' original application for donepezil hydrochloride, a generic version of an Alzheimer’s disease ther…

• FDA approval · 2014-10-26
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for donepezil hydrochloride (Rising Pharma Holdings, Inc.). This action indicates modifications to t…

• FDA approval · 2014-08-22
  FDA Approved: RIVASTIGMINE TARTRATE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved rivastigmine tartrate as an original ANDA for Macleods Pharmaceuticals Limited, creating a generic version of rivastigmine tart…

• FDA approval · 2014-08-13
  FDA Approved: NEURACEQ — Supplemental Application (Lantheus Biosciences Ltd.)

  The FDA approved a supplemental application for NEURACEQ (florbetaben F-18) submitted by Lantheus Biosciences Ltd.

• FDA approval · 2014-03-19
  FDA Approved: NEURACEQ — Original Application (Lantheus Biosciences Ltd.)

  FDA approved NEURACEQ (florbetaben F-18) for PET imaging to estimate beta-amyloid neuritic plaque density in adults with cognitive impairmen…

• FDA approval · 2014-02-05
  FDA Approved: FLUDEOXYGLUCOSE F 18 — Original Application (Washington University School of Medicine)

  FDA approves the original application for Fludeoxyglucose F-18 (FDG F-18), a radiopharmaceutical used in PET imaging to localize abnormal me…

• FDA approval · 2014-01-22
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved a generic version of donepezil hydrochloride (ANDA 202631) from Macleods Pharmaceuticals Limited.

• FDA approval · 2013-12-12
  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 · 2013-11-14
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for memantine hydrochloride submitted by Actavis Pharma, resulting in an approved modification t…

• FDA approval · 2013-11-08
  FDA Approved: AMYVID — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for AMYVID (florbetapir F-18) by Eli Lilly, updating its use as an imaging agent to estimate beta-am…

• FDA approval · 2013-11-07
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for Donepezil Hydrochloride from Macleods Pharmaceuticals Limited, enabling the marketing of the…

• FDA approval · 2013-10-25
  FDA Approved: VIZAMYL — Original Application (GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare))

  FDA approved Vizamyl (flutemetamol F-18) under an original application as a PET imaging agent to detect beta-amyloid plaques in adult patien…

• FDA approval · 2013-10-25
  FDA Approved: AMYVID — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for AMYVID (Florbetapir F-18) submitted by Eli Lilly and Company.

• FDA approval · 2013-10-24
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for memantine hydrochloride from Actavis Pharma, Inc. This action supplements the existing approval …

• FDA approval · 2013-09-20
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (ACI Healthcare USA, Inc.)

  FDA approved a supplemental application for donepezil hydrochloride (ACI Healthcare USA, Inc.), approving changes to the drug's labeling und…

• FDA approval · 2013-09-06
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

  The FDA approved Eisai's supplemental application for Aricept (donepezil hydrochloride).

• FDA approval · 2013-09-06
  FDA Approved: ARICEPT — Supplemental Application (Eisai Inc.)

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

• FDA approval · 2013-08-05
  FDA Approved: CERETEC — Supplemental Application (Medi-Physics Inc. dba GE Healthcare.)

  FDA approves a supplemental application for CERETEC (TECHNETIUM TC-99M EXAMETAZIME) from Medi-Physics Inc. dba GE Healthcare.