Essential Tremor

• CLINICAL_TRIALS trial_result · 2012-01-06
  Clinical Trial Update: A Pilot Efficacy and Safety Study of ST101 in Essential Tremor [Phase 2]

  Phase 2 pilot study of ST101 for essential tremor has completed, evaluating efficacy and safety.

• CLINICAL_TRIALS trial_result · 2012-01-06
  Clinical Trial Update: Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor [NA]

  The clinical trial comparing chronic versus intermittent deep brain stimulation for essential tremor has completed.

• CLINICAL_TRIALS trial_result · 2011-06-10
  Clinical Trial Update: A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause. [Phase 3]

  A Phase 3 trial compared Topiramate to placebo in essential tremor to evaluate efficacy and safety. The study status is completed.

• FDA approval · 2011-03-17
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Inderal LA (propranolol hydrochloride) filed by ANI Pharmaceuticals, Inc.

• FDA approval · 2011-01-14
  FDA Approved: DATSCAN — Original Application (Medi-Physics Inc. dba GE Healthcare.)

  FDA approved the original application for DATSCAN (ioflupane I-123), a radiopharmaceutical for brain imaging to aid in differentiating Parki…

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• CLINICAL_TRIALS trial_result · 2010-11-30
  Clinical Trial Update: Motor-related Cortical Potential in Patients With Essential Tremor [NA]

  The clinical trial investigating motor-related cortical potentials in patients with essential tremor has completed.

• CLINICAL_TRIALS trial_result · 2009-04-17
  Clinical Trial Update: Efficacy of Levetiracetam in Essential Tremor [Phase 1, Phase 2]

  A completed Phase 1/2 trial evaluated the efficacy of levetiracetam in patients with essential tremor.

• CLINICAL_TRIALS trial_result · 2009-01-21
  Clinical Trial Update: Novel Therapies for Essential Tremor [Phase 3]

  A Phase 3 clinical trial update on novel therapies for essential tremor sponsored by the U.S. Department of Veterans Affairs has completed.

• FDA approval · 2008-09-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride from Hikma Pharmaceuticals USA Inc., indicating regulatory approval of…

• FDA approval · 2008-03-20
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2008-03-20
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC, signifying approval of a gener…

• CLINICAL_TRIALS research · 2008-03-04
  Clinical Trial Update: 1-Octanol to Treat Essential Tremor [Phase 1]

  A Phase 1 clinical trial evaluating 1-octanol for essential tremor has completed. The study was sponsored by the National Institute of Neuro…

• CLINICAL_TRIALS trial_result · 2008-03-04
  Clinical Trial Update: 1-Octanol to Treat Essential Tremor [Phase 1]

  A Phase 1 clinical trial evaluating 1-octanol for essential tremor has completed.

• FDA approval · 2008-01-31
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a generic version of propranolol hydrochloride for the same indications as the brand product, enabling generic competition for …

• FDA approval · 2008-01-07
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2007-08-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma's generic propranolol hydrochloride product in an Original ANDA submission.

• FDA approval · 2007-06-21
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride (generic) from Hikma Pharmaceuticals USA Inc., indicating an approval …

• CLINICAL_TRIALS trial_result · 2007-04-04
  Clinical Trial Update: Octanol to Treat Essential Tremor [Phase 2]

  A Phase 2 clinical trial evaluating octanol as a treatment for essential tremor has completed.

• FDA label_change · 2007-02-21
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Inderal LA (propranolol hydrochloride) submitted by ANI Pharmaceuticals, Inc., resulting in labe…

• FDA approval · 2007-01-03
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INDERAL LA (propranolol hydrochloride) submitted by ANI Pharmaceuticals, Inc. This action au…