Restless Legs Syndrome

• EMA approval · 2026-04-07
  EMA Authorised: Neupro (rotigotine) — UCB Pharma S.A.

  The EMA has authorised Neupro (rotigotine) by UCB Pharma S.A. for Restless legs syndrome and Parkinson's disease.

• FDA approval · 2026-02-12
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for gabapentin by Ascend Laboratories, LLC, updating regulatory approval for this generic product.

• FDA approval · 2025-11-10
  FDA Approved: ROPINIROLE — Original Application (Elite Laboratories, Inc.)

  FDA approved Elite Laboratories, Inc.'s original application for a generic ropinirole product. The drug is indicated for Parkinson's disease…

• FDA approval · 2025-09-16
  FDA Approved: ROPINIROLE HYDROCHLORIDE — Supplemental Application (SOLCO HEALTHCARE US, LLC)

  FDA approved a supplemental application for ropinirole hydrochloride from Solco Healthcare US, LLC, approving an additional generic version …

• FDA approval · 2025-08-01
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental ANDA for Pramipexole dihydrochloride by Macleods Pharmaceuticals Limited, enabling marketing of a generic pr…

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• FDA approval · 2025-06-20
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

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

• FDA approval · 2025-04-25
  FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  The FDA approved a supplemental application for HORIZANT (gabapentin enacarbil) submitted by Azurity Pharmaceuticals. The approval updates t…

• FDA approval · 2025-03-31
  FDA Approved: ROPINIROLE — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for a generic version of Ropinirole from Solco Healthcare US, LLC.

• FDA approval · 2025-03-18
  FDA Approved: ROPINIROLE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for ropinirole from Accord Healthcare, finalizing an updated approval for this generic product.

• FDA approval · 2025-02-25
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for pramipexole dihydrochloride by Dr. Reddy's Laboratories Limited, enabling continued marketing of…

• FDA approval · 2025-02-19
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Vitruvias Therapeutics, Inc.)

  FDA approved a supplemental application to allow marketing of an extended-release formulation of pramipexole dihydrochloride for conditions …

• FDA approval · 2024-10-25
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for pramipexole dihydrochloride (Ingenus Pharmaceuticals) under an ANDA.

• FDA approval · 2024-05-06
  FDA Approved: ROPINIROLE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for ropinirole from Accord Healthcare Inc., indicating the generic product's approval under an ANDA.

• 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 · 2024-03-05
  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 · 2023-07-26
  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 · 2023-06-07
  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 · 2022-10-28
  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.