Parkinson Disease

• FDA approval · 2020-11-23
  FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Nuplazid (pimavanserin tartrate) submitted by Acadia Pharmaceuticals Inc., updating the labe…

• FDA approval · 2020-11-10
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for pramipexole dihydrochloride from Macleods Pharmaceuticals Limited.

• FDA approval · 2020-10-29
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for pramipexole dihydrochloride from Macleods Pharmaceuticals Limited. This action confirms regu…

• FDA approval · 2020-10-16
  FDA Approved: RASAGILINE — Supplemental Application (Alvogen, Inc.)

  FDA approved a supplemental application for Rasagiline by Alvogen, Inc., resulting in an approved supplemental application for the generic d…

• FDA approval · 2020-10-16
  FDA Approved: RASAGILINE — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Rasagiline from Micro Labs Limited. It confirms regulatory authorization for a generic rasagilin…

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• FDA approval · 2020-10-15
  FDA Approved: AMANTADINE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original application for amantadine, allowing a generic version to enter the market.

• FDA approval · 2020-10-14
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Pramipexole dihydrochloride from Dr. Reddy's Laboratories Limited under the ANDA program.

• FDA approval · 2020-08-31
  FDA Approved: INBRIJA — Supplemental Application (Merz Pharmaceuticals, LLC)

  FDA approved a supplemental application for INBRIJA (levodopa) submitted by Merz Pharmaceuticals, LLC.

• FDA approval · 2020-08-26
  FDA Approved: ROPINIROLE — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved a supplemental application for ropinirole from Accord Healthcare Inc. under an ANDA. This confirms continued availability o…

• FDA approval · 2020-08-21
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for Bromocriptine Mesylate submitted by Padagis US LLC.

• FDA approval · 2020-08-06
  FDA Approved: ROPINIROLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for ropinirole submitted by Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2020-06-16
  FDA Approved: AZILECT — Supplemental Application (Teva Neuroscience, Inc.)

  FDA approved a supplemental application for AZILECT (rasagiline mesylate) from Teva Neuroscience, Inc.

• FDA approval · 2020-05-21
  FDA Approved: DUOPA — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for DUOPA (carbidopa and levodopa) from AbbVie Inc. The action concerns an update to the approved pr…

• FDA approval · 2020-05-08
  FDA Approved: RASAGILINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Rasagiline submitted by Chartwell RX, LLC.

• FDA approval · 2020-04-24
  FDA Approved: ONGENTYS — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Ongentys (opicapone) as an add-on therapy to levodopa/carbidopa for adults with Parkinson's disease experiencing motor fluctuat…

• FDA approval · 2020-04-24
  FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for NEUPRO (rotigotine) submitted by UCB, Inc.

• FDA approval · 2020-04-07
  FDA Approved: ROPINIROLE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's supplemental application for ropinirole, a generic version used to treat Parkinson's disease …

• FDA approval · 2020-04-03
  FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for NEUPRO (rotigotine) from UCB, Inc. This action typically reflects changes to labeling and/or…

• FDA approval · 2020-04-03
  FDA Approved: CYCLOSET — Supplemental Application (Avvisto Therapeutics LLC)

  FDA approved a supplemental application for CYCLOSET (bromocriptine mesylate) submitted by Avvisto Therapeutics LLC.

• FDA approval · 2020-04-02
  FDA Approved: ROPINIROLE — Supplemental Application (Marlex Pharmaceuticals Inc)

  The FDA approved a supplemental application for ropinirole submitted by Marlex Pharmaceuticals Inc.

• FDA approval · 2020-03-30
  FDA Approved: ENTACAPONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Entacapone from Aurobindo Pharma Limited, granting approval of a generic entacapone product as a…

• FDA approval · 2020-03-25
  FDA Approved: DATSCAN — Supplemental Application (Medi-Physics Inc. dba GE Healthcare.)

  The FDA approved a supplemental application for DATSCAN (IOFLUPANE I-123) submitted by Medi-Physics Inc. dba GE Healthcare. This action upda…

• FDA approval · 2020-03-10
  FDA Approved: GOCOVRI — Supplemental Application (Adamas Pharma, LLC)

  FDA approves a supplemental application for GOCOVRI (amantadine) submitted by Adamas Pharma, LLC.

• FDA approval · 2020-03-10
  FDA Approved: AMANTADINE HYDROCHLORIDE — Original Application (Marlex Pharmaceuticals Inc)

  FDA approved amantadine hydrochloride as an original ANDA for a generic version. The product is manufactured by Marlex Pharmaceuticals Inc.

• FDA approval · 2020-03-03
  FDA Approved: SINEMET — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Sinemet (carbidopa and levodopa) from Organon LLC.