Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-10-13FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Wilshire Pharmaceuticals, Inc.)
FDA approved a supplemental application for dextroamphetamine sulfate by Wilshire Pharmaceuticals, Inc.
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FDA approval · 2023-10-11FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for Amphetamine Sulfate (amphetamine) from Amneal Pharmaceuticals NY LLC under ANDA211139.
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FDA approval · 2023-09-27FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's original ANDA for a generic mixture of dextroamphetamine and amphetamine salts (dextroamphetamine sacchara…
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FDA approval · 2023-09-12FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for methylphenidate hydrochloride, resulting in an approved modification to th…
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FDA approval · 2023-09-07FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for methylphenidate hydrochloride from Sun Pharmaceutical Industries, authorizing modifications …
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FDA approval · 2023-08-31FDA Approved: MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE PRODUCT — Original Application (SpecGx LLC)
FDA approved an original ANDA for a mixed-salts amphetamine product by SpecGx LLC, comprising multiple dextroamphetamine/amphetamine salts.
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CLINICAL_TRIALS trial_result · 2023-08-24Clinical Trial Update: Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) [Phase 2]
Phase 2 trial evaluating reboxetine for narcolepsy with cataplexy completed; results posted.
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FDA approval · 2023-08-24FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Golden State Medical Supply, Inc.)
FDA approved a supplemental ANDA from Golden State Medical Supply, Inc. to manufacture a generic combination of dextroamphetamine saccharate…
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FDA approval · 2023-07-12FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved the supplemental application for methylphenidate hydrochloride from Actavis Pharma, Inc., resulting in an approved supplemental…
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FDA approval · 2023-06-28FDA Approved: SUNOSI — Supplemental Application (Axsome Therapeutics, Inc.)
The FDA approved a supplemental application for Sunosi (solriamfetol) from Axsome Therapeutics, Inc., pertaining to updates to the drug's la…
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FDA approval · 2023-06-23FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
FDA approval of a supplemental application for a methylphenidate hydrochloride product from Lupin Pharmaceuticals, Inc.
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FDA approval · 2023-06-22FDA Approved: AMPHETAMINE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva's original application for generic Amphetamine, enabling marketing of amphetamine as a stimulant for ADHD and narcolepsy.
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FDA approval · 2023-06-21FDA Approved: MODAFINIL — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for a generic modafinil product (ANDA077667), enabling its marketing in the United Stat…
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FDA approval · 2023-05-01FDA Approved: LUMRYZ — Original Application (Avadel CNS Pharmaceuticals, LLC)
FDA approved LUMRYZ (sodium oxybate) from Avadel CNS Pharmaceuticals, LLC as an original application (NDA214755) for the treatment of narcol…
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CLINICAL_TRIALS trial_result · 2023-03-13Clinical Trial Update: An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy [Phase 2]
Phase 2 open-label trial of mazindol extended release (NLS-2) in narcolepsy with and without cataplexy completed.
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FDA approval · 2023-03-07FDA 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 amphetamine salt product, adding four amphetamine salt components (dextroamphetam…
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FDA approval · 2023-02-22FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for Granules Pharmaceuticals' generic four-salt amphetamine combination (dextroamphetamine saccharat…
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FDA approval · 2023-02-07FDA 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 product containing four amphetamine salts (dextroamphetamine saccharat…
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FDA approval · 2023-01-23FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals' generic combination amphetamine product containing dextroamphetamine saccharate, amphetamine aspartat…
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FDA approval · 2022-12-22FDA Approved: WAKIX — Supplemental Application (Harmony Biosciences, LLC)
The FDA approved a supplemental application for Wakix (pitolisant hydrochloride) submitted by Harmony Biosciences, LLC.
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FDA approval · 2022-12-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' supplemental application for methylphenidate hydrochloride (generic). This approval authorizes the manufac…
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FDA approval · 2022-12-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Neolpharma, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride (Neolpharma, Inc.) under an ANDA, granting regulatory approval for…
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FDA label_change · 2022-12-01FDA Approved: SUNOSI — Supplemental Application (Axsome Therapeutics, Inc.)
FDA approves Axsome Therapeutics' supplemental application for Sunosi (solriamfetol), signaling an updated labeling for the product.
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FDA approval · 2022-11-30FDA Approved: MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Mixed Salts of a Single Entity Amphetamine Product XR, a generic extended-release amphetamine pr…
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FDA approval · 2022-09-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceutical Inc)
FDA approved Camber Pharmaceutical Inc.'s supplemental application for methylphenidate hydrochloride (generic) under an Abbreviated New Drug…