Narcolepsy
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2014-05-09Clinical Trial Update: A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy [Phase 2]
Pfizer conducted a Phase 2 trial of a novel compound for excessive daytime sleepiness in narcolepsy; results were posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-05-09Clinical Trial Update: PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome [Phase 3]
Phase 3 clinical trial update for PROVIGIL (modafinil) in children and adolescents with excessive sleepiness due to narcolepsy or obstructiv…
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FDA label_change · 2014-04-11FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate by Hikma Pharmaceuticals USA Inc., resulting in a labeling update.
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FDA label_change · 2014-03-29FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for dextroamphetamine sulfate from Teva Pharmaceuticals USA, Inc., resulting in updated labeling…
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FDA approval · 2014-03-12FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a generic methylphenidate hydrochloride product from Amneal Pharmaceuticals of New York LLC under an Original Application, …
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CLINICAL_TRIALS research · 2014-03-04Clinical Trial Update: Narcolepsy - New Potential Treatment [NA]
A clinical trial update notes a potential new treatment for narcolepsy. The current status of the trial is unknown.
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FDA approval · 2014-02-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental application for a generic combination of amphetamine salts (dextroamphetamine saccharate, amphetamine a…
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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 · 2014-01-22FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)
FDA approves a supplemental ANDA for a combination of amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate monohydrate, de…
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FDA approval · 2014-01-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical Industries' supplemental application for methylphenidate hydrochloride. The approval pertains to a labeling …
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FDA approval · 2013-12-31FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)
The FDA approved a supplemental application for Epic Pharma's generic combination of amphetamine salts (dextroamphetamine saccharate, amphet…
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FDA approval · 2013-12-31FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride (generic) from Lannett Company, Inc., confirming regulatory approv…
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FDA approval · 2013-12-20FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate from Hikma Pharmaceuticals USA, resulting in labeling updates for the product.
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FDA approval · 2013-12-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for a generic methylphenidate hydrochloride CD product by Lannett Company, expanding the availab…
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FDA approval · 2013-12-13FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2013-12-13FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental NDA for methylphenidate from Sandoz Inc.
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FDA approval · 2013-12-03FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for a four-salt dextroamphetamine/amphetamine product manufactured by Prasco Laboratories.
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FDA approval · 2013-11-27FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (NorthStar RxLLC)
FDA approved NorthStar RxLLC's generic mixed amphetamine salts product (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetami…
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CLINICAL_TRIALS trial_result · 2013-11-25Clinical Trial Update: Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy [Phase 3]
Phase 3 trial of Xyrem (sodium oxybate) for narcolepsy has been completed. Results were posted on November 25, 2013.
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FDA approval · 2013-09-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for a generic fixed-combination amphetamine product containing dextroamphetamine saccharate, am…
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FDA approval · 2013-09-23FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lannett Company, Inc.)
The FDA approved Lannett Company's original application for methylphenidate hydrochloride, enabling the marketing of a generic methylphenida…
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FDA approval · 2013-09-19FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved a supplemental application for methylphenidate hydrochloride submitted by Cranbury Pharmaceuticals, LLC. The approval confi…
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FDA approval · 2013-07-31FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (Aurolife Pharma, LLC)
FDA approved Aurolife Pharma, LLC's dextroamphetamine sulfate as an original-application generic, authorizing a generic stimulant for attent…
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FDA approval · 2013-07-09FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lannett Company, Inc.)
FDA approved the original ANDA for a generic methylphenidate hydrochloride product by Lannett Company, Inc.
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FDA approval · 2013-06-14FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental NDA for a four-salt amphetamine product (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextro…