Alcohol Withdrawal Syndrome
📧 Sign up to get email alerts when something new happens for Alcohol Withdrawal Syndrome.
Sign up freeTop drugs studied for this disease
-
CLINICAL_TRIALS trial_result · 2017-07-17Clinical Trial Update: Dexmedetomidine (Precedex®) for Severe Alcohol Withdrawal Syndrome (AWS) and Alcohol Withdrawal Delirium (AWD) [Phase 4]
A Phase 4 trial evaluating dexmedetomidine (Precedex) for severe alcohol withdrawal syndrome and alcohol withdrawal delirium was terminated.…
-
CLINICAL_TRIALS trial_result · 2017-05-05Clinical Trial Update: Preventing Alcohol Withdrawal With Oral Baclofen [Phase 2]
Phase 2 trial evaluated whether oral baclofen could prevent alcohol withdrawal in individuals with alcohol use disorder; the study was termi…
-
FDA approval · 2016-12-16FDA Approved: DIAZEPAM — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved a supplemental application for Diazepam from Oceanside Pharmaceuticals, resulting in changes to the drug's labeling.
-
FDA approval · 2016-12-16FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for chlordiazepoxide hydrochloride (generic) from Chartwell RX, LLC, updating the approval of this g…
-
FDA approval · 2016-12-16FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE — Supplemental Application (Epic Pharma LLC)
The FDA approved a supplemental application for chlordiazepoxide hydrochloride from Epic Pharma LLC, confirming regulatory clearance for a g…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2016-12-16FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental application for chlordiazepoxide hydrochloride, authorizing changes to the approved product (such as la…
-
FDA approval · 2016-06-24FDA Approved: DIAZEPAM — Original Application (Chartwell Governmental & Specialty RX, LLC.)
FDA approved the original application for diazepam oral from Chartwell Governmental & Specialty RX, LLC. This marks approval of a generic di…
-
FDA approval · 2016-05-02FDA Approved: DIAZEPAM INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Diazepam Intensol from Hikma Pharmaceuticals USA Inc., confirming changes to the approved pr…
-
CLINICAL_TRIALS trial_result · 2016-04-11Clinical Trial Update: Treatment of Alcohol Withdrawal in Hospital Patients [Phase 4]
Sponsored by Virginia Commonwealth University, the Phase 4 trial evaluating treatment for Alcohol Withdrawal Syndrome in hospitalized patien…
-
FDA approval · 2016-03-24FDA Approved: DIAZEPAM — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application to Chartwell RX, LLC for diazepam oral solution (concentrate), authorizing a generic version of this…
-
CLINICAL_TRIALS trial_result · 2016-01-13Clinical Trial Update: Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
A completed clinical trial evaluating quality improvement strategies for benzodiazepine-resistant alcohol withdrawal syndrome.
-
FDA approval · 2015-04-06FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)
The FDA approved Hospira, Inc.'s supplemental application for diazepam (generic) under the ANDA.
-
FDA approval · 2015-03-09FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a Teva supplemental application for Diazepam, resulting in an approved labeling change under ANDA 071321.
-
CLINICAL_TRIALS trial_result · 2015-01-30Clinical Trial Update: The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS)
The clinical trial update reports on the completed study evaluating the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) for predicti…
-
FDA approval · 2014-04-14FDA Approved: DIAZEPAM — Original Application (Chartwell RX, LLC)
FDA approved Chartwell RX, LLC's original application for diazepam oral solution (concentrate) as a generic product.
-
CLINICAL_TRIALS trial_result · 2014-03-18Clinical Trial Update: Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome [Phase 4]
A Phase 4 comparative trial evaluated gamma-hydroxybutyrate versus oxazepam for treating alcohol withdrawal syndrome and has completed.
-
FDA approval · 2013-01-28FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for diazepam from Teva Pharmaceuticals USA, Inc. The action represents an additional approval or mod…
-
FDA approval · 2012-09-13FDA Approved: LORAZEPAM — Supplemental Application (International Medication Systems, Limited)
FDA approved a supplemental application for lorazepam from International Medication Systems, Limited.
-
FDA approval · 2010-01-20FDA Approved: CLORAZEPATE DIPOTASSIUM — Supplemental Application (NORTHSTAR RX LLC)
The FDA approved a supplemental application for clorazepate dipotassium submitted by Northstar RX LLC.
-
CLINICAL_TRIALS trial_result · 2009-12-30Clinical Trial Update: Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome [Phase 3]
A Phase 3 trial evaluated the efficacy and safety of levetiracetam for inpatient treatment of Alcohol Withdrawal Syndrome; the study has com…
-
FDA approval · 2008-07-23FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for diazepam filed by Teva Pharmaceuticals USA, Inc., updating/expanding its labeling.
-
CLINICAL_TRIALS trial_result · 2006-12-08Clinical Trial Update: Trial of Safety Nets In Hospitalized Patients [Phase 3]
Phase 3 trial evaluating Safety Nets in hospitalized patients with delirium, agitation, alcohol withdrawal, and related cognitive disturbanc…
-
CLINICAL_TRIALS trial_result · 2006-10-18Clinical Trial Update: Antiglutamate Anticonvulsants in the Treatment of Alcohol Withdrawal Syndrome [NA]
A completed clinical trial evaluated antiglutamate anticonvulsants (topiramate, lamotrigine, memantine) with diazepam and placebo for alcoho…