Shift Work Sleep Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-01-20FDA Approved: ARMODAFINIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for armodafinil filed by Mylan Pharmaceuticals, granting regulatory approval for the indicated s…
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CLINICAL_TRIALS trial_result · 2015-07-29Clinical Trial Update: Fire Fighter Fatigue Management Program: Operation Healthy Sleep [NA]
A completed clinical trial evaluating the Fire Fighter Fatigue Management Program 'Operation Healthy Sleep' for shift-work sleep disorders a…
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FDA approval · 2015-04-16FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)
The FDA approved a supplemental application for NUVIGIL (armodafinil) filed by Cephalon, LLC.
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FDA approval · 2015-02-09FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)
The FDA approved a supplemental application for Nuvigil (armodafinil) filed by Cephalon, LLC.
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FDA approval · 2015-01-15FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)
The FDA approved a supplemental application for Modafinil submitted by CIMA Labs Inc., resulting in updated regulatory labeling for the prod…
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FDA approval · 2014-11-05FDA Approved: MODAFINIL — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Modafinil submitted by Rising Pharma Holdings, Inc. The approval indicates the sponsor's supplem…
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FDA approval · 2014-02-03FDA Approved: MODAFINIL — Original Application (Apotex Corp.)
The FDA approved the original application for generic modafinil by Apotex Corp., authorizing their modafinil product as a generic version.
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FDA approval · 2012-10-18FDA Approved: MODAFINIL — Original Application (Alembic Pharmaceuticals Limited)
FDA approves Alembic Pharmaceuticals Limited's Original Application for Modafinil as a generic version of the wakefulness-promoting drug. Th…
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FDA approval · 2012-09-27FDA Approved: MODAFINIL — Original Application (Rising Pharma Holdings, Inc.)
FDA approved a generic form of modafinil from Rising Pharma Holdings, Inc.
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FDA approval · 2012-09-26FDA Approved: MODAFINIL — Original Application (Bionpharma Inc.)
FDA approved Bionpharma's original application for a generic Modafinil product, authorizing marketing in the United States for the treatment…
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CLINICAL_TRIALS trial_result · 2012-06-20Clinical Trial Update: Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder [Phase 4]
Phase 4 trial evaluating the efficacy and tolerability of armodafinil in adults with excessive sleepiness due to shift work disorder; result…
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FDA approval · 2012-06-01FDA Approved: ARMODAFINIL — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved an original application for armodafinil from Mylan Pharmaceuticals Inc., enabling a generic version of the wakefulness-promotin…
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FDA approval · 2010-10-21FDA 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.
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CLINICAL_TRIALS research · 2010-06-23Clinical Trial Update: Sleep Enhancement Training Study for Novice Shiftworkers [Phase 1]
A Phase 1 clinical trial evaluating a Sleep Enhancement Training program for novice shift workers with Shift work sleep disorder has complet…
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CLINICAL_TRIALS trial_result · 2010-06-23Clinical Trial Update: Sleep Enhancement Training Study for Experienced Shiftworkers [Phase 1]
Phase 1 trial of sleep enhancement training for experienced shift workers has completed.
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CLINICAL_TRIALS trial_result · 2010-03-31Clinical 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…
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CLINICAL_TRIALS trial_result · 2010-03-31Clinical Trial Update: Sleepiness and Brain Function: The Effect of Armodafinil in Shift Work Sleep Disorder
Clinical trial results assess the effect of armodafinil on sleepiness and brain function in shift work sleep disorder. The study status is C…
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CLINICAL_TRIALS trial_result · 2010-02-22Clinical 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…
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CLINICAL_TRIALS trial_result · 2010-02-03Clinical Trial Update: Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL [Phase 3]
Phase 3 trial evaluating efficacy and pharmacokinetics of armodafinil (Provigil) in shift work sleep disorder completed; results posted in 2…
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CLINICAL_TRIALS trial_result · 2009-09-23Clinical Trial Update: Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD [Phase 3]
A Phase 3 trial evaluating armodafinil (CEP-10953) for excessive daytime sleepiness in shift work sleep disorder has completed and results w…
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FDA approval · 2009-03-26FDA 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…
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FDA approval · 2007-08-17FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)
FDA approved a supplemental application for Modafinil submitted by CIMA Labs Inc. to update the product's labeling under the supplemental fi…
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FDA approval · 2007-06-15FDA Approved: NUVIGIL — Original Application (Cephalon, LLC)
FDA approved NUVIGIL (armodafinil) in its original application from Cephalon, LLC. It is approved for excessive daytime sleepiness associate…
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FDA approval · 2006-08-07FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)
FDA approved a supplemental application for Modafinil submitted by CIMA Labs Inc., resulting in an approved change to its labeling.