Parkinson Disease

• FDA approval · 2018-12-19
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approval of a generic pramipexole dihydrochloride product under an Original Application (ANDA) by Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2018-11-29
  FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for NEUPRO (rotigotine) from UCB, Inc., resulting in updated labeling for the drug.

• FDA approval · 2018-10-03
  FDA Approved: ENTACAPONE — Original Application (Lannett Company, Inc.)

  FDA approved an original application for entacapone, a generic COMT inhibitor, to be used in combination with levodopa/carbidopa for Parkins…

• FDA approval · 2018-09-21
  FDA Approved: CARBIDOPA, LEVODOPA, AND ENTACAPONE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental NDA from Sandoz Inc to market a fixed-dose combination of carbidopa, levodopa, and entacapone for Parkinson's di…

• FDA approval · 2018-08-07
  FDA Approved: TOLCAPONE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approves a new original application for Tolcapone from Ingenus Pharmaceuticals, expanding access to this COMT inhibitor for use in Parki…

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• FDA approval · 2018-07-27
  FDA Approved: RASAGILINE — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original application for a generic rasagiline product (Rasagiline). Rasagiline is used in the treatment of …

• FDA approval · 2018-07-10
  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, indicating an approval of a suppl…

• FDA approval · 2018-05-07
  FDA Approved: CARBIDOPA — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original application for carbidopa (generic) by Zydus Pharmaceuticals USA Inc., enabling a generic carbidopa product to be …

• FDA approval · 2017-12-13
  FDA Approved: AMANTADINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for amantadine hydrochloride from Upsher-Smith Laboratories to update the product's labeling.

• FDA approval · 2017-10-30
  FDA Approved: RASAGILINE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' original application for rasagiline as a generic treatment for Parkinson disease.

• FDA approval · 2017-10-20
  FDA Approved: CARBIDOPA — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' Original Application for carbidopa, confirming a generic carbidopa product is approvable. Carbidopa is u…

• FDA approval · 2017-10-17
  FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)

  FDA approved a supplemental application for NUPLAZID (pimavanserin tartrate) submitted by Acadia Pharmaceuticals.

• FDA approval · 2017-08-31
  FDA Approved: ENTACAPONE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved the original ANDA for Entacapone from Ajanta Pharma USA Inc. as a generic option for use with levodopa/carbidopa in Parkinson's…

• FDA approval · 2017-08-24
  FDA Approved: GOCOVRI — Original Application (Adamas Pharma, LLC)

  FDA approved GOCOVRI (amantadine) extended-release for the treatment of dyskinesia in patients with Parkinson's disease who are on levodopa …

• FDA approval · 2017-06-21
  FDA Approved: AMANTADINE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original ANDA for amantadine, enabling the marketing of a generic version.

• FDA approval · 2017-06-16
  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) filed by MDD US Operations LLC (a subsidiary of Supernus Pharma…

• FDA approval · 2017-06-12
  FDA Approved: AMANTADINE HYDROCHLORIDE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's Original Application for amantadine hydrochloride, authorizing the marketing of a generic formulation.

• FDA approval · 2017-06-09
  FDA Approved: AMANTADINE HYDROCHLORIDE — Original Application (Strides Pharma Inc.)

  FDA approved an Original Application for amantadine hydrochloride by Strides Pharma Inc., granting generic approval for this product.

• FDA approval · 2017-06-07
  FDA Approved: AMANTADINE HYDROCHLORIDE — Original Application (Strides Pharma Inc.)

  FDA approved the original application for amantadine hydrochloride from Strides Pharma Inc., enabling a generic version of the drug.

• FDA approval · 2017-06-05
  FDA Approved: ENTACAPONE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Entacapone (Macleods Pharmaceuticals Limited) under an Original Application (ANDA) for the U.S. market. Entacapone is used as a…

• FDA approval · 2017-03-21
  FDA Approved: XADAGO — Original Application (MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.)

  FDA approved XADAGO (safinamide mesylate) in an Original Application for Parkinson's disease. The applicant/manufacturer is MDD US Operation…

• FDA approval · 2017-02-28
  FDA Approved: ROPINIROLE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s generic ropinirole under an Original Application (ANDA 204022) for indications including Parkinson's d…

• FDA approval · 2017-01-30
  FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)

  The FDA has approved a supplemental application for NEUPRO (rotigotine) submitted by UCB, Inc. No specific changes are detailed in the excer…

• FDA approval · 2017-01-23
  FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves an original application for pramipexole dihydrochloride from Macleods Pharmaceuticals Limited.

• FDA approval · 2016-12-15
  FDA Approved: AMANTADINE HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved amantadine hydrochloride as an Original Application, enabling generic availability for the drug.