Narcolepsy
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS safety_alert · 2015-04-02Clinical Trial Update: Risk of Narcolepsy Associated With Administration of H1N1 Vaccine
This ClinicalTrials.gov update discusses the risk of narcolepsy potentially associated with administration of an H1N1 influenza vaccine, wit…
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FDA approval · 2015-03-20FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for methylphenidate hydrochloride submitted by SpecGx LLC. This action updates the product via a…
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FDA approval · 2015-03-02FDA Approved: DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE — Supplemental Application (SpecGx LLC)
The FDA granted approval of a supplemental application for dextroamphetamine sulfate extended-release from SpecGx LLC, updating the regulato…
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FDA approval · 2015-02-27FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approval of a supplemental application for sodium oxybate filed by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2015-02-25FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals' methylphenidate hydrochloride generic through an Original Application (ANDA 204115).
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FDA approval · 2015-02-23FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate from Hikma Pharmaceuticals USA Inc., indicating an FDA-approved change to the pro…
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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 · 2015-02-04FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for a generic product containing four amphetamine salt components. The approval supports use for att…
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FDA approval · 2015-02-04FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)
FDA approved a supplemental application for a generic combination of amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate,…
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FDA approval · 2015-01-29FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for dextroamphetamine sulfate by Teva Pharmaceuticals USA, Inc. This action represents an approv…
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FDA approval · 2015-01-29FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for dextroamphetamine sulfate from SpecGx LLC under an Abbreviated New Drug Application.
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FDA approval · 2015-01-29FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application from Sandoz Inc for a generic mixed amphetamine salt product containing dextroamphetamine and amphet…
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FDA approval · 2015-01-29FDA Approved: DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental ANDA for a generic fixed-dose combination of dextroamphetamine and amphetamine salts (dextroamphetamine sacchara…
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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 · 2015-01-15FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's supplemental application for a generic product containing the four amphetamine salt components (mixed amph…
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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 · 2014-11-03FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)
FDA approved a supplemental application for a generic fixed-dose combination of dextroamphetamine and amphetamine salts manufactured by Epic…
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FDA approval · 2014-09-15FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)
FDA approved a supplemental application for METHYLIN (methylphenidate hydrochloride) submitted by Shionogi Inc.
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FDA approval · 2014-09-12FDA Approved: EVEKEO — Supplemental Application (Azurity Pharmaceuticals, Inc.)
The FDA approved a supplemental application for EVEKEO (amphetamine sulfate) from Azurity Pharmaceuticals, Inc., resulting in an updated lab…
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CLINICAL_TRIALS trial_result · 2014-09-11Clinical Trial Update: A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy [Phase 2]
Phase 2 trial evaluating safety and effectiveness of ADX-N05 for excessive daytime sleepiness in narcolepsy has completed with posted result…
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FDA approval · 2014-07-24FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for a product containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine …
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FDA label_change · 2014-07-14FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) filed by Novartis Pharmaceuticals Corporation, resul…
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CLINICAL_TRIALS trial_result · 2014-06-12Clinical Trial Update: Clarithromycin for the Treatment of Hypersomnia [Phase 2]
A Phase 2 trial evaluating clarithromycin for hypersomnia disorders (hypersomnia, idiopathic hypersomnia, and narcolepsy) has completed with…
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FDA approval · 2014-06-10FDA 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 fixed-dose combination of amphetamine salts (dextroamphetamine saccharate, amphet…
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CLINICAL_TRIALS trial_result · 2014-05-23Clinical Trial Update: A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy [Phase 2]
A Phase 2 safety and effectiveness study of a single dose of JNJ-17216498 in patients with narcolepsy has completed.