Parkinson Disease

• FDA approval · 2020-03-02
  FDA Approved: AMANTADINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma's generic amantadine hydrochloride (oral) under an Original Application (ANDA 210129), authorizing its market…

• FDA approval · 2020-02-21
  FDA Approved: ROPINIROLE HYDROCHLORIDE — Supplemental Application (SOLCO HEALTHCARE US, LLC)

  FDA approved a supplemental application for ropinirole hydrochloride (Solco Healthcare US, LLC), enabling the marketing of the generic produ…

• FDA approval · 2020-01-02
  FDA Approved: RASAGILINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for Rasagiline submitted by Ascend Laboratories, LLC. This action updates the Rasagiline product…

• FDA approval · 2020-01-02
  FDA Approved: RASAGILINE — Supplemental Application (Alvogen, Inc.)

  The FDA approved Alvogen's supplemental application for Rasagiline (generic) under an ANDA, enabling a generic Rasagiline tablet for Parkins…

• FDA approval · 2019-12-30
  FDA Approved: CARBIDOPA, LEVODOPA, AND ENTACAPONE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for the Carbidopa/Levodopa/Entacapone combination from Sandoz Inc.

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• FDA approval · 2019-12-17
  FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application to the NDA for Carbidopa and Levodopa from Zydus Pharmaceuticals USA Inc., approving changes under t…

• FDA approval · 2019-12-13
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a Supplemental Application for Bromocriptine Mesylate by ANI Pharmaceuticals, Inc. The provided excerpt does not specify a new …

• FDA approval · 2019-12-05
  FDA Approved: DUOPA — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for DUOPA (carbidopa and levodopa) submitted by AbbVie.

• FDA approval · 2019-11-25
  FDA Approved: XADAGO — Supplemental Application (MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for XADAGO (safinamide mesylate) from MDD US Operations LLC, a subsidiary of Supernus Pharmaceut…

• FDA approval · 2019-11-21
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA supplemental approval granted to Torrent Pharmaceuticals Limited for pramipexole dihydrochloride, a generic product, enabling its market…

• FDA approval · 2019-11-21
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

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

• FDA approval · 2019-11-15
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental ANDA for pramipexole dihydrochloride from Alembic Pharmaceuticals Limited. The product is a generic treatment op…

• FDA approval · 2019-10-21
  FDA Approved: CARBIDOPA — Original Application (NorthStar Rx LLC)

  FDA approved the original ANDA for a generic carbidopa product from NorthStar Rx LLC.

• FDA approval · 2019-10-10
  FDA Approved: FLUORODOPA F18 — Original Application (THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH)

  FDA approved Fluorodopa F18 (FDOPA F-18) under an original application as a radiopharmaceutical for PET imaging of the brain's dopaminergic …

• FDA approval · 2019-10-04
  FDA Approved: RASAGILINE MESYLATE — Original Application (Avet Pharmaceuticals Inc.)

  The FDA approved Avet Pharmaceuticals' original application for rasagiline mesylate as a generic treatment option for Parkinson's disease.

• FDA approval · 2019-08-29
  FDA Approved: INBRIJA — Supplemental Application (Merz Pharmaceuticals, LLC)

  The FDA approved a supplemental application for INBRIJA (levodopa) from Merz Pharmaceuticals, LLC. The action updates the approved product, …

• FDA approval · 2019-08-27
  FDA Approved: NOURIANZ — Original Application (Kyowa Kirin, Inc.)

  FDA approved NOURIANZ (istradefylline) as an add-on therapy to levodopa/carbidopa for adults with Parkinson's disease to reduce off time.

• FDA approval · 2019-08-19
  FDA Approved: ZELAPAR — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for Zelapar (selegiline hydrochloride) submitted by Bausch Health US, LLC.

• FDA approval · 2019-06-05
  FDA Approved: CARBIDOPA AND LEVODOPA — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's Original Abbreviated New Drug Application for Carbidopa and Levodopa (generic). The product i…

• FDA approval · 2019-04-02
  FDA Approved: SELEGILINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved an original application for Selegiline hydrochloride tablets from Rising Pharma Holdings, Inc., granting generic approval. The …

• FDA approval · 2019-03-29
  FDA Approved: RASAGILINE — Original Application (Micro Labs Limited)

  The FDA approved Micro Labs Limited's original application for rasagiline, establishing a generic option for use in Parkinson's disease. Thi…

• FDA approval · 2019-01-18
  FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for NEUPRO (rotigotine) submitted by UCB, Inc., resulting in an approved labeling update for the…

• FDA approval · 2019-01-02
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's generic pramipexole dihydrochloride under an Original Application (ANDA). The drug is indicat…

• FDA approval · 2018-12-21
  FDA Approved: INBRIJA — Original Application (Merz Pharmaceuticals, LLC)

  The FDA approved INBRIJA (levodopa inhalation powder) under an original application from Merz Pharmaceuticals, LLC.

• FDA approval · 2018-12-20
  FDA Approved: AZILECT — Supplemental Application (Teva Neuroscience, Inc.)

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