Parkinson Disease

• EMA approval · 2024-05-02
  EMA Authorised: Mirapexin (pramipexole dihydrochloride monohydrate) — Boehringer Ingelheim International GmbH

  The European Medicines Agency authorized Mirapexin (pramipexole dihydrochloride monohydrate) for restless legs syndrome and Parkinson's dise…

• EMA approval · 2024-04-25
  EMA Authorised: Sifrol (pramipexole dihydrochloride monohydrate) — Boehringer Ingelheim International GmbH

  The EMA authorized Sifrol (pramipexole dihydrochloride monohydrate) from Boehringer Ingelheim for restless legs syndrome and Parkinson's dis…

• FDA approval · 2024-04-09
  FDA Approved: RASAGILINE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings, Inc.'s rasagiline mesylate under an original application (ANDA 218163). This marks the approval of …

• FDA approval · 2024-03-05
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for pramipexole dihydrochloride from Aurobindo Pharma Limited, enabling the generic product for …

• FDA approval · 2023-09-12
  FDA Approved: IOFLUPANE I 123 — Supplemental Application (Curium US LLC)

  FDA approved a supplemental application for IOFLUPANE I-123 (DaTSCAN) from Curium US LLC.

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• FDA approval · 2023-07-26
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for pramipexole dihydrochloride from Torrent Pharmaceuticals Limited under an ANDA.

• FDA approval · 2023-07-03
  FDA Approved: BENZTROPINE MESYLATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for benztropine mesylate, submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2023-06-07
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Pramipexole dihydrochloride from Macleods Pharmaceuticals Limited under ANDA202164.

• FDA approval · 2023-06-07
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

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

• FDA approval · 2023-05-31
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Pramipexole Dihydrochloride from Alembic Pharmaceuticals Limited.

• FDA approval · 2023-05-26
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Vitruvias Therapeutics, Inc.)

  The FDA approved a supplemental application to market an extended-release formulation of pramipexole dihydrochloride by Vitruvias Therapeuti…

• FDA approval · 2023-05-10
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark Pharmaceuticals' supplemental application for pramipexole dihydrochloride (generic).

• FDA approval · 2023-02-28
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for pramipexole dihydrochloride from Alembic Pharmaceuticals Limited, expanding the availability of …

• FDA approval · 2022-11-30
  FDA Approved: DATSCAN — Supplemental Application (Medi-Physics Inc. dba GE Healthcare.)

  FDA approved a supplemental application for DATSCAN (IOFLUPANE I-123) by Medi-Physics Inc. dba GE Healthcare, indicating an update to the la…

• FDA approval · 2022-11-28
  FDA Approved: CARBIDOPA AND LEVODOPA — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic carbidopa-levodopa product under an Original Application by Aurobindo Pharma Limited.

• FDA approval · 2022-11-21
  FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for Amneal Pharmaceuticals NY LLC for CARBIDOPA AND LEVODOPA (carbidopa-levodopa).

• FDA approval · 2022-11-08
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for bromocriptine mesylate from Sandoz Inc, approving a modification to an existing generic product'…

• FDA approval · 2022-11-01
  FDA Approved: DATSCAN — Supplemental Application (Medi-Physics Inc. dba GE Healthcare.)

  FDA approved a supplemental application for DATSCAN (ioflupane I-123) by Medi-Physics Inc. dba GE Healthcare.

• FDA approval · 2022-10-28
  FDA Approved: ROPINIROLE — Supplemental Application (Marlex Pharmaceuticals Inc)

  FDA approved a supplemental application for a generic ropinirole product manufactured by Marlex Pharmaceuticals Inc.

• FDA approval · 2022-10-27
  FDA Approved: ROPINIROLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for ropinirole submitted by Glenmark Pharmaceuticals Inc., USA, updating the approved product.

• FDA approval · 2022-10-27
  FDA Approved: ROPINIROLE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for ropinirole submitted by Bionpharma Inc., under an already approved ANDA.

• FDA approval · 2022-09-21
  FDA Approved: CARBIDOPA-LEVODOPA — Original Application (Advagen Pharma Ltd.,)

  The FDA approved Advagen Pharma's original application for a generic carbidopa-levodopa product.

• FDA approval · 2022-07-28
  FDA Approved: DHIVY — Supplemental Application (Avion Pharmaceuticals, LLC)

  FDA approved a supplemental application for DHIVY, a carbidopa-levodopa product from Avion Pharmaceuticals, LLC. The action approves changes…

• FDA approval · 2022-06-30
  FDA Approved: DHIVY — Supplemental Application (Avion Pharmaceuticals, LLC)

  The FDA approved a supplemental application for DHIVY (carbidopa-levodopa) from Avion Pharmaceuticals, LLC.

• FDA approval · 2022-05-11
  FDA Approved: ROPINIROLE — Original Application (Solco Healthcare US, LLC)

  The FDA approved Solco Healthcare US, LLC's original application for a generic ropinirole product, marking approval to treat conditions incl…