Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-11-16FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA entry documenting a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc. as part of the regulatory ap…
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FDA approval · 2017-10-18FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (SUNRISE PHARMACEUTICAL, INC.)
FDA approved Sunrise Pharmaceutical's generic dextroamphetamine sulfate under an original application (ANDA210059).
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CLINICAL_TRIALS trial_result · 2017-10-06Clinical Trial Update: Body Weight Regulation in Patients With Narcolepsy
This update reports on a completed study examining body weight regulation in patients with narcolepsy.
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FDA approval · 2017-09-14FDA Approved: MODAFINIL — Original Application (Zydus Lifesciences Limited)
FDA approves the original generic application for modafinil by Zydus Lifesciences Limited.
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FDA approval · 2017-08-16FDA Approved: MODAFINIL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA approves an original generic application for modafinil, manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc…
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FDA approval · 2017-07-28FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Trigen Laboratories, LLC)
FDA approved an original application for methylphenidate hydrochloride from Trigen Laboratories, LLC.
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FDA approval · 2017-07-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII — Original Application (Alvogen Inc.)
FDA approves a generic combination tablet containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amp…
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CLINICAL_TRIALS trial_result · 2017-07-02Clinical Trial Update: Sleep Disorders of Patients With Diseases of the Nervous System
This clinical trial update notes the completion of a National Institute of Neurological Disorders and Stroke study investigating sleep disor…
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FDA approval · 2017-05-19FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) submitted by Amneal Pharmaceuticals LLC.
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FDA approval · 2017-05-11FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (KVK-TECH, INC.)
FDA approved the original application for methylphenidate hydrochloride from KVK-Tech, Inc., granting a generic version of this stimulant fo…
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CLINICAL_TRIALS trial_result · 2017-03-10Clinical Trial Update: Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy [Phase 2]
Phase 2 clinical trial evaluating GSK189254 for narcolepsy has been terminated.
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FDA approval · 2017-02-07FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)
FDA approved a supplemental application for NuVigil (armodafinil) submitted by Cephalon, LLC.
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FDA approval · 2017-02-01FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (KVK-Tech, Inc.)
FDA approved a supplemental application for Dextroamphetamine sulfate from KVK-Tech, Inc., under an ANDA. This action confirms approval of a…
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CLINICAL_TRIALS trial_result · 2017-01-31Clinical Trial Update: Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy. [Phase 3]
Phase 3 trial evaluating BF2.649 for excessive daytime sleepiness in narcolepsy has completed.
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CLINICAL_TRIALS trial_result · 2017-01-31Clinical Trial Update: Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant) [Phase 3]
A Phase 3 long-term open-label study of pitolisant (BF2.649) for narcolepsy with cataplexy has completed.
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FDA approval · 2017-01-26FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate from Hikma Pharmaceuticals USA Inc.
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CLINICAL_TRIALS trial_result · 2017-01-25Clinical Trial Update: Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia
This clinical trial update notes the completion of a study evaluating cardiovascular variability and heart rate arousal response in idiopath…
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FDA approval · 2017-01-06FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (NorthStar RxLLC)
The FDA approved a supplemental ANDA for a generic combination of amphetamine salts (dextroamphetamine and amphetamine sulfates) from NorthS…
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FDA approval · 2017-01-06FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application from Prasco Laboratories for a generic combination of four amphetamine salts (dextroamphetamine …
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FDA approval · 2017-01-04FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for dextroamphetamine sulfate from Prasco Laboratories.
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FDA approval · 2017-01-04FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application to add dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amph…
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FDA approval · 2017-01-04FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for a generic combination of dextroamphetamine and amphetamine salts manufactured by Sandoz Inc.
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FDA approval · 2017-01-04FDA Approved: DEXTROAMPHETAMINE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
FDA approved a supplemental application for the generic dextroamphetamine from Cranbury Pharmaceuticals, confirming continued approval of th…
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FDA approval · 2017-01-04FDA Approved: DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for a generic combination amphetamine product (dextroamphetamine saccharate/amphetamine aspartat…
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FDA approval · 2017-01-04FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for a generic product containing the four amphetamine salt components: dextroamphetamine saccharate,…