Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-04-11FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for methylphenidate hydrochloride from Dr. Reddy's Laboratories Inc, updating the approval for the g…
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FDA approval · 2024-04-10FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Northstar Rx LLC)
The FDA approved a supplemental application for methylphenidate hydrochloride from Northstar Rx LLC, authorizing the generic product. Methyl…
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FDA approval · 2024-04-01FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for methylphenidate hydrochloride.
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FDA approval · 2024-04-01FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Elite Laboratories, Inc.)
The FDA approved Elite Laboratories, Inc.'s supplemental application for a fixed combination of amphetamine salts (dextroamphetamine sacchar…
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FDA approval · 2024-04-01FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE EXTENDED-RELEASE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's supplemental application for a generic mixed amphetamine salts extended-release product (dextroamphetamine…
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FDA approval · 2024-03-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for a generic product containing four amphetamine salt components, manufactured by Sun Pharmaceu…
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FDA approval · 2024-03-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' supplemental ANDA for a generic combination of amphetamine/dextroamphetamine salts used to treat attention…
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FDA approval · 2024-03-28FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for methylphenidate hydrochloride, a generic stimulant product, enabling it…
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FDA label_change · 2024-03-12FDA Approved: AMPHETAMINE EXTENDED-RELEASE — Supplemental Application (Neos Therapeutics, LP)
The FDA approved a supplemental application for AMPHETAMINE EXTENDED-RELEASE by Neos Therapeutics, LP.
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FDA approval · 2024-03-08FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (KVK-Tech, Inc.)
FDA approved a supplemental application for dextroamphetamine sulfate from KVK-Tech, Inc., making the generic product available via an appro…
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FDA approval · 2024-02-28FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride from Sun Pharmaceutical Industries, expanding the approval status …
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FDA approval · 2024-02-27FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Eywa Pharma Inc)
FDA approves Eywa Pharma Inc's supplemental application for methylphenidate hydrochloride, a generic ADHD medication, under an ANDA.
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FDA approval · 2024-02-27FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for Granules Pharmaceuticals' combination amphetamine salts product (dextroamphetamine saccharate, a…
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FDA approval · 2024-02-27FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application from Granules Pharmaceuticals Inc. for a generic product containing four amphetamine/dextroamphetami…
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FDA approval · 2024-01-26FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (NorthStar RxLLC)
FDA approved NorthStar RxLLC's supplemental application for a generic four-salt amphetamine/dextroamphetamine product (dextroamphetamine sac…
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FDA approval · 2024-01-26FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Oryza Pharmaceuticals Inc.)
FDA approved a supplemental application for a generic product containing four amphetamine salts (dextroamphetamine saccharate, amphetamine a…
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FDA approval · 2024-01-16FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Sodium Oxybate submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2024-01-16FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Aurolife Pharma, LLC)
FDA approved a supplemental application for amphetamine sulfate manufactured by Aurolife Pharma, LLC.
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FDA approval · 2024-01-11FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Trigen Laboratories, LLC)
FDA approved a supplemental application for methylphenidate hydrochloride from Trigen Laboratories, LLC.
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CLINICAL_TRIALS trial_result · 2024-01-09Clinical Trial Update: An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy [Phase 4]
Phase 4 interventional safety study in narcolepsy completed; results posted.
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CLINICAL_TRIALS trial_result · 2023-11-01Clinical Trial Update: Awareness and Self-Compassion Enhancing Narcolepsy Treatment [NA]
A completed clinical trial investigating awareness and self-compassion as a treatment approach for narcolepsy (including with and without ca…
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FDA approval · 2023-10-31FDA Approved: LUMRYZ — Supplemental Application (Avadel CNS Pharmaceuticals, LLC)
FDA approved a supplemental application for LUMRYZ (sodium oxybate) from Avadel CNS Pharmaceuticals, LLC to support its use for narcolepsy.
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FDA approval · 2023-10-20FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII — Supplemental Application (Alvogen Inc.)
FDA approves Alvogen Inc.'s supplemental application to market generic mixed amphetamine salts tablets (dextroamphetamine/amphetamines) in m…
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FDA approval · 2023-10-20FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for methylphenidate hydrochloride (generic). This approval supports the ava…
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FDA approval · 2023-10-20FDA Approved: DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application from SpecGx LLC for a generic product containing dextroamphetamine saccharate and amphetamine aspart…