Restless Legs Syndrome
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-07-26FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for pramipexole dihydrochloride from Torrent Pharmaceuticals Limited under an ANDA.
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FDA approval · 2023-06-07FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Pramipexole dihydrochloride from Macleods Pharmaceuticals Limited under ANDA202164.
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FDA approval · 2023-06-07FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
The FDA approved a supplemental application for a generic pramipexole dihydrochloride product from Macleods Pharmaceuticals Limited.
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FDA approval · 2023-05-31FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for Pramipexole Dihydrochloride from Alembic Pharmaceuticals Limited.
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FDA approval · 2023-05-26FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Vitruvias Therapeutics, Inc.)
The FDA approved a supplemental application to market an extended-release formulation of pramipexole dihydrochloride by Vitruvias Therapeuti…
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FDA approval · 2023-05-10FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark Pharmaceuticals' supplemental application for pramipexole dihydrochloride (generic).
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CLINICAL_TRIALS trial_result · 2023-04-24Clinical Trial Update: RCT for Pregabalin in Restless Legs Syndrome in South Korea [Phase 3]
Phase 3 randomized trial of pregabalin for restless legs syndrome has been completed in South Korea.
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FDA approval · 2023-02-28FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for pramipexole dihydrochloride from Alembic Pharmaceuticals Limited, expanding the availability of …
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FDA approval · 2022-10-28FDA Approved: ROPINIROLE — Supplemental Application (Marlex Pharmaceuticals Inc)
FDA approved a supplemental application for a generic ropinirole product manufactured by Marlex Pharmaceuticals Inc.
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FDA approval · 2022-10-27FDA Approved: ROPINIROLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved a supplemental application for ropinirole submitted by Glenmark Pharmaceuticals Inc., USA, updating the approved product.
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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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CLINICAL_TRIALS trial_result · 2022-10-14Clinical Trial Update: Pitolisant in Refractory Restless Legs Syndrome [Phase 4]
Phase 4 clinical trial update for pitolisant in refractory restless legs syndrome.
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CLINICAL_TRIALS trial_result · 2022-09-21Clinical Trial Update: DIalysis Symptom COntrol-Restless Legs Syndrome Trial [Phase 3]
Phase 3 trial update for a dialysis-related symptom control program targeting Restless Legs Syndrome in patients with End Stage Renal Diseas…
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CLINICAL_TRIALS trial_result · 2022-09-14Clinical Trial Update: Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia [Phase 2]
Phase 2 randomized, placebo-controlled trial of ferric carboxymaltose in restless legs syndrome with iron-deficiency anemia was terminated. …
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CLINICAL_TRIALS trial_result · 2022-09-06Clinical Trial Update: Sublingual Apomorphine in Refractory Restless Legs Syndrome [Phase 4]
Phase 4 clinical trial update evaluating sublingual apomorphine for refractory Restless Legs Syndrome.
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CLINICAL_TRIALS trial_result · 2022-08-24Clinical Trial Update: The Effect of Vitamin C and E Therapy on Restless Leg Syndrome in Patients With End Stage Renal Disease on Haemodialysis [Phase 3]
A Phase 3 trial evaluating the effect of vitamin C and E therapy on restless legs syndrome in patients with end-stage renal disease on haemo…
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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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CLINICAL_TRIALS trial_result · 2022-02-24Clinical Trial Update: The Effect of Horizant (Gabapentin Enacarbil) on Augmentation [NA]
A completed clinical trial evaluating the effect of Horizant (gabapentin enacarbil) on augmentation in restless legs syndrome. Results poste…
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EMA withdrawal · 2022-02-18EMA Withdrawn: Leganto (rotigotine) — UCB Pharma S.A.
Leganto (rotigotine) has been withdrawn from the market by UCB Pharma S.A., affecting treatment areas including restless legs syndrome and P…
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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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CLINICAL_TRIALS trial_result · 2021-12-09Clinical Trial Update: Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients [Phase 4]
Phase 4 trial update for pramipexole in restless legs syndrome patients undergoing peritoneal dialysis has been terminated.
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CLINICAL_TRIALS withdrawal · 2021-11-16Clinical Trial Update: Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome [Phase 4]
A Phase 4 trial of pregabalin for Restless Legs Syndrome was withdrawn.
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CLINICAL_TRIALS trial_result · 2021-11-16Clinical Trial Update: Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome [Phase 4]
Phase 4 randomized trial update comparing gabapentin and gabapentin enacarbil for Restless Leg Syndrome; study TERMINATED.
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CLINICAL_TRIALS trial_result · 2021-10-12Clinical Trial Update: Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS [Phase 3]
Phase 3 placebo-controlled trial evaluating the efficacy and safety of Injectafer for Restless Legs Syndrome has completed with results post…