Narcolepsy
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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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FDA approval · 2015-11-23FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (KVK-Tech, Inc.)
FDA approved a generic version of dextroamphetamine sulfate under an Original Application for KVK-Tech, Inc., making this product available …
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EMA approval · 2015-11-20Narcolepsy treatment recommended for approval
The European Medicines Agency recommends approving a treatment for narcolepsy, indicating a potential new therapy option for patients with n…
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CLINICAL_TRIALS trial_result · 2015-11-18Clinical Trial Update: Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) [Phase 3]
Phase 3 trial update on pitolisant (BF2.649) as add-on to sodium oxybate for narcolepsy.
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FDA approval · 2015-11-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals,Inc.)
FDA approved Lupin Pharmaceuticals' generic methylphenidate hydrochloride product via Original Application, making a generic version of meth…
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FDA approval · 2015-09-22FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Camber Pharmaceutical Inc)
The FDA approved Camber Pharmaceutical's methylphenidate hydrochloride as an Original Application, providing a generic version of the stimul…
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FDA approval · 2015-08-20FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Actavis's generic dextroamphetamine/amphetamine salt product. The approval updates labeling and …
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FDA approval · 2015-08-17FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate by Hikma Pharmaceuticals USA Inc., updating its regulatory status for this produc…
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FDA approval · 2015-08-14FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals,Inc.)
FDA approved Lupin Pharmaceuticals' methylphenidate hydrochloride generic under an Original Application (ANDA 204602); this provides a gener…
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FDA approval · 2015-06-15FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride CD from Lannett Company, Inc.
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FDA approval · 2015-06-02FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate from Sandoz Inc.
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CLINICAL_TRIALS trial_result · 2015-05-29Clinical Trial Update: A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics [Phase 1]
Phase 1, single-dose study of JZP-386 to evaluate safety, pharmacokinetics and pharmacodynamics has completed, sponsored by Concert Pharmace…
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FDA approval · 2015-04-17FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental NDA from Prasco Laboratories for a generic mixture of amphetamine salts: dextroamphetamine saccharate, amphetami…
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FDA approval · 2015-04-17FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) from Amneal Pharmaceuticals LLC.
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FDA approval · 2015-04-17FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for dextroamphetamine sulfate submitted by SpecGx LLC.
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FDA approval · 2015-04-17FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approves a supplemental application for Dextroamphetamine Sulfate from Prasco Laboratories.
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FDA approval · 2015-04-17FDA Approved: DEXTROAMPHETAMINE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved a supplemental application for a dextroamphetamine product from Cranbury Pharmaceuticals, LLC.
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FDA approval · 2015-04-17FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (NorthStar RxLLC)
The FDA approved a supplemental application from NorthStar RxLLC for a generic combination of four amphetamine salts (dextroamphetamine sacc…
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FDA approval · 2015-04-17FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride CD submitted by Lannett Company, Inc., resulting in continued appr…
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FDA approval · 2015-04-17FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)
FDA approved Epic Pharma, LLC's supplemental application for a generic combination product containing dextroamphetamine saccharate, amphetam…
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FDA approval · 2015-04-17FDA 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 (dextroamphetamine saccharate, …
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FDA approval · 2015-04-17FDA Approved: DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approves a supplemental application from SpecGx LLC for a generic product containing four amphetamine/dextroamphetamine salt forms, enab…
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FDA approval · 2015-04-17FDA Approved: EVEKEO — Supplemental Application (Azurity Pharmaceuticals, Inc.)
The FDA approved a supplemental application for EVEKEO (amphetamine sulfate) submitted by Azurity Pharmaceuticals, Inc., under ANDA200166. T…
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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 · 2015-04-03FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for dextroamphetamine sulfate from Actavis Pharma, Inc. under an ANDA.