Parkinson Disease

• FDA approval · 2022-05-05
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (ScieGen Pharmaceuticals Inc)

  The FDA approved a supplemental application for ScieGen Pharmaceuticals Inc to market a generic pramipexole dihydrochloride product for the …

• FDA approval · 2022-04-27
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for bromocriptine mesylate submitted by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2022-03-30
  FDA Approved: IOFLUPANE I 123 — Original Application (Curium US LLC)

  The FDA approved IOFLUPANE I-123 (IOFLUPANE I-123) from Curium US LLC in an Original Application as a dopamine transporter imaging agent for…

• FDA approval · 2022-02-23
  FDA Approved: APOMORPHINE HYDROCLORIDE — Original Application (TruPharma, LLC)

  FDA approved a generic apomorphine hydrochloride product under Original Application (ANDA212025) from TruPharma, LLC for use in Parkinson's …

• FDA approval · 2022-02-03
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved Ingenus Pharmaceuticals' original Abbreviated New Drug Application for pramipexole dihydrochloride (generic), a dopamine ag…

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• FDA approval · 2022-01-25
  FDA Approved: CARBIDOPA, LEVODOPA AND ENTACAPONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma's original application for a generic fixed-dose combination of carbidopa, levodopa, and entacapone. This approval…

• EMA approval · 2022-01-19
  EMA Refused: Nouryant (Istradefylline) — Kyowa Kirin Holdings B.V.

  The EMA refused approval for Nouryant (istradefylline) for Parkinson's disease from Kyowa Kirin Holdings B.V.

• FDA approval · 2022-01-04
  FDA Approved: ENTACAPONE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's original application for Entacapone. Entacapone is a COMT inhibitor used as an adjunct to lev…

• FDA approval · 2021-11-18
  FDA Approved: RASAGILINE — Original Application (Carnegie Pharmaceuticals LLC)

  The FDA approved Carnegie Pharmaceuticals' original application for Rasagiline (rasagiline mesylate), a generic monoamine oxidase-B inhibito…

• FDA approval · 2021-11-12
  FDA Approved: DHIVY — Original Application (Avion Pharmaceuticals, LLC)

  FDA approves DHIVY, an original-application carbidopa/levodopa product from Avion Pharmaceuticals.

• FDA approval · 2021-10-14
  FDA Approved: BENZTROPINE MESYLATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original application for benztropine mesylate (generic) from Hikma Pharmaceuticals USA Inc., for use in treating Parkinsoni…

• FDA approval · 2021-10-05
  FDA Approved: CARBIDOPA AND LEVODOPA — Original Application (Radha Pharmaceuticals Inc)

  The FDA approved Radha Pharmaceuticals Inc's original ANDA for a generic carbidopa-levodopa product, used to treat Parkinson's disease.

• EMA approval · 2021-09-28
  EMA Authorised: Entacapone Teva (entacapone) — Teva Pharma B.V.

  Entacapone Teva has been authorised for use in the treatment of Parkinson's disease in the EU.

• FDA approval · 2021-08-20
  FDA Approved: AMANTADINE HYDROCHLORIDE — Original Application (Patrin Pharma, Inc.)

  FDA approved Patrin Pharma, Inc.'s original application for amantadine hydrochloride, enabling production and marketing of this generic drug…

• FDA approval · 2021-08-06
  FDA Approved: XADAGO — Supplemental Application (MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for XADAGO (safinamide mesylate) submitted by MDD US Operations LLC, a subsidiary of Supernus Pharma…

• FDA approval · 2021-07-12
  FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for NEUPRO (rotigotine) filed by UCB, Inc., indicating a regulatory expansion to the product’s label…

• FDA approval · 2021-06-11
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE — Original Application (Vitruvias Therapeutics, Inc.)

  FDA approved an extended-release pramipexole dihydrochloride tablet under an Original Application for Vitruvias Therapeutics, indicated for …

• FDA approval · 2021-05-07
  FDA Approved: CARBIDOPA AND LEVODOPA — Original Application (ScieGen Pharmaceuticals Inc)

  FDA approved the original approval application for a generic carbidopa/levodopa product from ScieGen Pharmaceuticals Inc.

• FDA approval · 2021-03-12
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application from Aurobindo Pharma Limited for pramipexole dihydrochloride (ANDA 202633).

• FDA approval · 2021-02-09
  FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for carbidopa and levodopa from Sun Pharmaceutical Industries, expanding the approval for this g…

• FDA approval · 2021-02-04
  FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Carbidopa and Levodopa from Teva Pharmaceuticals USA, Inc., updating the product under the exist…

• FDA approval · 2021-02-02
  FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for carbidopa and levodopa by Mylan Pharmaceuticals Inc., reflecting changes to an already approved …

• FDA approval · 2021-01-14
  FDA Approved: RASAGILINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for Rasagiline submitted by Ascend Laboratories, LLC.

• FDA approval · 2021-01-14
  FDA Approved: RASAGILINE MESYLATE — Supplemental Application (Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Rasagiline Mesylate filed by Avet Pharmaceuticals, approving a generic version of the Parkin…

• FDA approval · 2020-12-11
  FDA Approved: FLUORODOPA F18 — Supplemental Application (THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH)

  FDA approved a supplemental application for Fluorodopa F18, enabling updated labeling/indications for its use in brain PET imaging. The appr…