Narcolepsy

• CLINICAL_TRIALS trial_result · 2011-11-30
  Clinical Trial Update: Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy [Phase 3]

  Phase 3 trial results compare oral Xyrem (sodium oxybate) and Modafinil with placebo for daytime sleepiness in narcolepsy.

• FDA approval · 2011-10-25
  FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (Wilshire Pharmaceuticals, Inc.)

  The FDA approved Wilshire Pharmaceuticals' generic dextroamphetamine sulfate under an original ANDA. The product is intended for the same in…

• EMA safety_alert · 2011-02-18
  European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix

  EMA is reviewing additional data on potential association between narcolepsy and the Pandemrix vaccine used for influenza vaccination.

• FDA approval · 2010-12-10
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  The FDA approved a supplemental application for methylphenidate hydrochloride submitted by SpecGx LLC.

• FDA approval · 2010-12-09
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for methylphenidate by Sandoz Inc, resulting in an updated label for the product.

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• FDA label_change · 2010-12-09
  FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) submitted by Novartis, resulting in updated labeling for…

• FDA approval · 2010-11-12
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for a four-salt amphetamine product (dextroamphetamine saccharate, amphetam…

• FDA approval · 2010-10-21
  FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)

  FDA approved a supplemental application for modafinil submitted by CIMA Labs, resulting in changes to the drug's labeling.

• FDA approval · 2010-10-18
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for methylphenidate hydrochloride CD from Lannett Company, Inc. under NDA 021259, authorizing co…

• FDA approval · 2010-09-23
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for a Sandoz generic combination of four amphetamine salt components (dextroamphetamine and amphetam…

• EMA safety_alert · 2010-09-23
  European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy

  EMA provides updates on the review of Pandemrix and reports of narcolepsy, focusing on safety signals and ongoing assessment.

• CLINICAL_TRIALS trial_result · 2010-06-25
  Clinical Trial Update: Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome [Phase 3]

  This Phase 3 clinical trial update reports results from a study evaluating patient-reported outcomes with armodafinil in adults with narcole…

• FDA approval · 2010-04-27
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc.

• CLINICAL_TRIALS trial_result · 2010-03-31
  Clinical Trial Update: Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness [Phase 3]

  Extension Phase 3 study of armodafinil for excessive daytime sleepiness, including narcolepsy and related sleep disorders, completed with re…

• CLINICAL_TRIALS trial_result · 2010-02-22
  Clinical Trial Update: Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder [Phase 3]

  Phase 3 clinical trial results for armodafinil (CEP-10953) in treating narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work…

• CLINICAL_TRIALS trial_result · 2010-01-21
  Clinical Trial Update: Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy [Phase 3]

  Phase 3 safety and efficacy study of armodafinil for excessive sleepiness in narcolepsy completed with results posted.

• FDA approval · 2009-08-11
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application from Teva Pharmaceuticals USA, Inc. for a combination of four amphetamine salts: dextroamphetamine s…

• FDA approval · 2009-05-28
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)

  FDA approved Epic Pharma LLC's supplemental application for a generic product containing four amphetamine salts: dextroamphetamine saccharat…

• FDA approval · 2009-04-16
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental NDA for Methylphenidate Hydrochloride CD (generic from Lannett) to authorize its continued marketing as a methyl…

• CLINICAL_TRIALS research · 2009-04-03
  Clinical Trial Update: Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition [NA]

  A clinical trial is evaluating intranasal Orexin A effects on the IL-6 system, sleep-wake regulation, and neurocognition in narcolepsy; spon…

• FDA approval · 2009-03-26
  FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)

  FDA approved a supplemental application for NUVIGIL (armodafinil) submitted by Cephalon, LLC. This approval covers changes to the product la…

• FDA approval · 2008-11-12
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Prasco Laboratories to market a generic combination of amphetamine salts (dextroamphetamine sacc…

• FDA approval · 2008-08-11
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's generic combination of four amphetamine salts: dextroamphetamine saccharate, amphetamine …

• FDA approval · 2008-05-23
  FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) from Amneal Pharmaceuticals LLC.

• FDA approval · 2008-02-06
  FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for dextroamphetamine sulfate, a generic stimulant indicated for atte…