Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2013-06-11FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) from Amneal Pharmaceuticals LLC, resulting in cha…
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FDA approval · 2013-06-07FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc.
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FDA approval · 2013-06-07FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) from Novartis Pharmaceuticals Corporation, signaling an …
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FDA approval · 2013-05-29FDA Approved: DEXTROAMPHETAMINE — Original Application (Cranbury Pharmaceuticals, LLC)
FDA approves Cranbury Pharmaceuticals' original ANDA for dextroamphetamine, a generic stimulant indicated for attention-deficit/hyperactivit…
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FDA approval · 2013-05-06FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc under NDA 021284, marking an additional approval for the…
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FDA approval · 2013-05-06FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for methylphenidate hydrochloride CD from Lannett Company, Inc., authorizing its marketing as a …
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CLINICAL_TRIALS trial_result · 2013-04-25Clinical Trial Update: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies [NA]
This trial evaluated a method for assessing driving ability in patients with wakefulness pathologies such as narcolepsy and hypersomnia. The…
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FDA approval · 2013-03-08FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application from Prasco Laboratories for a generic combination of amphetamine salts (dextroamphetamine saccharat…
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CLINICAL_TRIALS trial_result · 2013-02-11Clinical Trial Update: Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy [Phase 3]
Phase 3 study evaluating BF2.649 with add-on Modafinil for cataplexy in narcolepsy has completed, reporting efficacy and safety findings.
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FDA approval · 2012-12-19FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methylphenidate hydrochloride from SpecGx LLC, indicating regulatory approval for an existing ge…
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FDA approval · 2012-12-19FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methylphenidate hydrochloride from SpecGx LLC. The approval confirms the generic product's appro…
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FDA approval · 2012-12-17FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc., resulting in updated labeling.
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EMA research · 2012-10-19European Medicines Agency reviews hypothesis on Pandemrix and development of narcolepsy
The European Medicines Agency reviews the hypothesis linking the Pandemrix vaccine to narcolepsy development, evaluating potential causality…
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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 · 2012-08-24Clinical Trial Update: Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy [Phase 3]
A Phase 3 study evaluating modafinil (Provigil) for excessive sleepiness in children and adolescents with narcolepsy has completed.
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FDA approval · 2012-07-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE (LA) — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved the original application for methylphenidate hydrochloride (LA) from Teva Pharmaceuticals USA, Inc. as a long-acting generic st…
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FDA approval · 2012-06-22FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Original Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma's generic combination of four amphetamine salt components under an Original Application (ANDA) for ADHD and narc…
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CLINICAL_TRIALS trial_result · 2012-06-11Clinical Trial Update: Efficacy and Safety Study 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, assessing efficacy and safety.
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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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CLINICAL_TRIALS trial_result · 2012-05-31Clinical Trial Update: Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness [Phase 3]
A Phase 3 trial evaluating Provigil (modafinil) for safety and efficacy in children and adolescents with narcolepsy has completed.
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FDA approval · 2012-03-27FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Teva’s generic combination of four amphetamine salts (dextroamphetamine saccharate, amphetam…
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FDA approval · 2012-02-07FDA 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 combination (dextroamphetamine saccharate, amph…
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FDA approval · 2011-12-01FDA Approved: METHYLPHENIDATE HYDROCHLORIDE (LA) — Original Application (Dr. Reddy's Laboratories Inc)
FDA approved the original application for a generic methylphenidate hydrochloride extended-release product (LA) from Dr. Reddy's Laboratorie…