Parkinson Disease
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Sign up freeTop drugs studied for this disease
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EMA approval · 2025-04-08EMA Authorised: Azilect (rasagiline) — Teva B.V.
The EMA authorized Azilect (rasagiline) for Parkinson disease with Teva B.V. as the marketing authorization holder. Decision date: 07/04/202…
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FDA approval · 2025-03-31FDA Approved: ROPINIROLE — Supplemental Application (Solco Healthcare US, LLC)
FDA approved a supplemental application for a generic version of Ropinirole from Solco Healthcare US, LLC.
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FDA approval · 2025-03-18FDA 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.
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FDA approval · 2025-03-07FDA Approved: CARBIDOPA AND LEVODOPA — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Carbidopa and Levodopa from Rising Pharma Holdings, Inc. to bring a generic product to market.
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FDA approval · 2025-02-25FDA 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…
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FDA approval · 2025-02-19FDA 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 …
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FDA approval · 2025-02-11FDA Approved: BENZTROPINE MESYLATE — Original Application (QUAGEN PHARMACEUTICALS LLC)
The FDA approved the original application for benztropine mesylate (generic) from Quagen Pharmaceuticals LLC. It is indicated for Parkinson'…
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FDA approval · 2025-02-07FDA Approved: ONGENTYS — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for ONGENTYS (opicapone) submitted by Amneal Pharmaceuticals LLC.
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FDA approval · 2025-02-03FDA Approved: ONAPGO — Original Application (MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc)
FDA approved ONAPGO (apomorphine hydrochloride) from MDD US Operations, LLC (a subsidiary of Supernus Pharmaceuticals) under an Original NDA…
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EMA approval · 2025-01-22EMA Authorised: Levodopa/Carbidopa/Entacapone Orion (levodopa;carbidopa;entacapone) — Orion Corporation
The European Medicines Agency authorised Levodopa/Carbidopa/Entacapone Orion for the treatment of Parkinson's disease, manufactured by Orion…
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FDA approval · 2025-01-14FDA Approved: CARBIDOPA AND LEVODOPA — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original application for a generic Carbidopa/Levodopa product.
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EMA approval · 2025-01-06EMA Authorised: Stalevo (levodopa;carbidopa;entacapone) — Orion Corporation
The EMA has authorised Stalevo, a fixed-dose combination of levodopa, carbidopa and entacapone, for Parkinson's disease, with Orion Corporat…
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EMA approval · 2024-11-15EMA Authorised: Celsunax (ioflupane (123i)) — Pinax Pharma GmbH
EMA authorised Celsunax (ioflupane (123I)) by Pinax Pharma GmbH for radionuclide imaging to aid the assessment of movement disorders and dem…
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FDA approval · 2024-10-25FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
FDA approved a supplemental application for pramipexole dihydrochloride (Ingenus Pharmaceuticals) under an ANDA.
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FDA approval · 2024-09-26FDA Approved: AMANTADINE HYDROCHLORIDE — Original Application (Zhejiang Jutai Pharmaceutical Co., Ltd.)
The FDA approved an original ANDA for amantadine hydrochloride from Zhejiang Jutai Pharmaceutical Co., Ltd., providing a generic version of …
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EMA approval · 2024-09-24EMA Authorised: Entacapone Orion (entacapone) — Orion Corporation
Entacapone Orion has been authorised in the EU for Parkinson's disease; Orion Corporation is the marketing authorisation holder.
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EMA approval · 2024-09-18EMA Authorised: Comtan (entacapone) — Orion Corporation
European Medicines Agency authorised Comtan (entacapone) for Parkinson disease with Orion Corporation as the marketing authorisation holder.
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EMA approval · 2024-09-18EMA Authorised: Comtess (entacapone) — Orion Corporation
EMA has authorised Comtess (entacapone) by Orion Corporation for the treatment of Parkinson's disease; entacapone is a COMT inhibitor used a…
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EMA approval · 2024-09-02EMA Authorised: Pramipexole Teva (pramipexole dihydrochloride monohydrate) — Teva Pharma B.V.
The EMA authorised Pramipexole Teva (pramipexole dihydrochloride monohydrate) for use in Parkinson disease, with Teva Pharma B.V. as the mar…
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EMA approval · 2024-08-20EMA Authorised: Oprymea (pramipexole dihydrochloride monohydrate) — Krka, d.d., Novo mesto
EMA has authorised Oprymea (pramipexole dihydrochloride monohydrate) for the treatment of Parkinson's disease, under the marketing authorisa…
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FDA approval · 2024-08-07FDA Approved: CREXONT — Original Application (Amneal Pharmaceuticals LLC)
The FDA approved CREXONT, a carbidopa-levodopa product from Amneal Pharmaceuticals, under an Original Application (NDA217186).
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FDA approval · 2024-08-02FDA Approved: BENZTROPINE MESYLATE — Supplemental Application (ScieGen Pharmaceuticals Inc)
FDA approved a supplemental application for Benztropine Mesylate submitted by ScieGen Pharmaceuticals Inc.
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FDA approval · 2024-06-28FDA Approved: RASAGILINE — Original Application (Macleods Pharmaceuticals Limited)
The FDA approved the original application for a generic rasagiline product manufactured by Macleods Pharmaceuticals Limited.
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FDA approval · 2024-06-04FDA Approved: CARBIDOPA AND LEVODOPA — Original Application (Advagen Pharma Ltd)
FDA approves Advagen Pharma Ltd's original application for a generic carbidopa/levodopa product indicated for Parkinson's disease.
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FDA approval · 2024-05-06FDA 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.