Restless Legs Syndrome
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-10-27FDA Approved: ROPINIROLE — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for ropinirole submitted by Bionpharma Inc., under an already approved ANDA.
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FDA approval · 2022-05-11FDA Approved: ROPINIROLE — Original Application (Solco Healthcare US, LLC)
The FDA approved Solco Healthcare US, LLC's original application for a generic ropinirole product, marking approval to treat conditions incl…
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FDA approval · 2022-05-05FDA 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 …
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FDA approval · 2022-02-03FDA 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 · 2021-07-12FDA 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…
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FDA approval · 2021-06-11FDA 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 …
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FDA approval · 2021-03-12FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application from Aurobindo Pharma Limited for pramipexole dihydrochloride (ANDA 202633).
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FDA approval · 2020-11-10FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
The FDA approved a supplemental application for pramipexole dihydrochloride from Macleods Pharmaceuticals Limited.
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FDA approval · 2020-10-29FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
The FDA approved a supplemental application for pramipexole dihydrochloride from Macleods Pharmaceuticals Limited. This action confirms regu…
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FDA approval · 2020-10-14FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for Pramipexole dihydrochloride from Dr. Reddy's Laboratories Limited under the ANDA program.
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FDA approval · 2020-08-26FDA Approved: ROPINIROLE — Supplemental Application (Accord Healthcare Inc.)
The FDA approved a supplemental application for ropinirole from Accord Healthcare Inc. under an ANDA. This confirms continued availability o…
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FDA approval · 2020-08-06FDA Approved: ROPINIROLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for ropinirole submitted by Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2020-04-24FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)
The FDA approved a supplemental application for NEUPRO (rotigotine) submitted by UCB, Inc.
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FDA approval · 2020-04-17FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))
The FDA approved a supplemental application for Horizant (gabapentin enacarbil) submitted by Azurity Pharmaceuticals (formerly Arbor Pharmac…
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FDA approval · 2020-04-07FDA Approved: ROPINIROLE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic Pharmaceuticals Limited's supplemental application for ropinirole, a generic version used to treat Parkinson's disease …
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FDA approval · 2020-04-03FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)
The FDA approved a supplemental application for NEUPRO (rotigotine) from UCB, Inc. This action typically reflects changes to labeling and/or…
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FDA approval · 2020-04-02FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))
FDA approved a supplemental application for HORIZANT (gabapentin enacarbil) submitted by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharm…
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FDA approval · 2020-04-02FDA Approved: ROPINIROLE — Supplemental Application (Marlex Pharmaceuticals Inc)
The FDA approved a supplemental application for ropinirole submitted by Marlex Pharmaceuticals Inc.
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FDA approval · 2020-02-21FDA 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…
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FDA approval · 2019-11-21FDA 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…
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FDA approval · 2019-11-21FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
The FDA approved a supplemental application for Pramipexole dihydrochloride from Macleods Pharmaceuticals Limited.
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FDA approval · 2019-11-15FDA 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…
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FDA approval · 2019-01-18FDA 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…
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FDA approval · 2019-01-02FDA 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…
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FDA approval · 2018-12-19FDA 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.