Restless Legs Syndrome
📧 Sign up to get email alerts when something new happens for Restless Legs Syndrome.
Sign up freeTop drugs studied for this disease
-
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…
-
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 …
-
CLINICAL_TRIALS trial_result · 2021-06-09Clinical Trial Update: An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS [Phase 4]
An extension Phase 4 trial evaluating efficacy and safety of HORIZANT in adolescents with moderate-to-severe primary restless legs syndrome.
-
CLINICAL_TRIALS trial_result · 2021-06-09Clinical Trial Update: An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS [Phase 4]
Phase 4 trial evaluating efficacy and safety of HORIZANT in adolescents with moderate-to-severe primary restless legs syndrome.
-
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).
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS withdrawal · 2021-01-22Clinical Trial Update: 12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects [Phase 3]
A Phase 3 trial evaluating pregabalin for Restless Legs Syndrome was withdrawn.
-
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.
-
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…
-
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.
-
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…
-
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.
-
FDA approval · 2020-04-24FDA Approved: NEUPRO — Supplemental Application (UCB, Inc.)
The FDA approved a supplemental application for NEUPRO (rotigotine) submitted by UCB, Inc.
-
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…
-
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 …
-
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…
-
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…
-
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.
-
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…
-
CLINICAL_TRIALS trial_result · 2020-02-18Clinical Trial Update: A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome [NA]
A completed clinical trial evaluating MMF07 Foot Massager and heat therapy for Restless Legs Syndrome; results posted in 2020.
-
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…
-
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.
-
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…
-
CLINICAL_TRIALS trial_result · 2019-09-04Clinical Trial Update: Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation [NA]
Completed clinical trial investigating sensory counter-stimulation for treatment of Restless Legs Syndrome/Willis-Ekbom Disease; results pos…
-
CLINICAL_TRIALS trial_result · 2019-07-10Clinical Trial Update: A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients [Phase 4]
Phase 4 study assessing oral gabapentin enacarbil in Japanese patients with restless legs syndrome completed, with results posted in July 20…
-
CLINICAL_TRIALS trial_result · 2019-03-15Clinical Trial Update: Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome) [Phase 3]
Phase 3 trial update comparing conversion from immediate-release to controlled-release ropinirole for Restless Legs Syndrome has completed w…