Narcolepsy
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-06EMA Authorised: Wakix (pitolisant) — Bioprojet Pharma
Wakix (pitolisant) has been authorised by the EMA for narcolepsy.
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FDA approval · 2026-04-23FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application from Prasco Laboratories for the four mixed amphetamine salt components: dextroamphetamine saccharat…
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FDA approval · 2026-04-21FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for methylphenidate hydrochloride from Amneal Pharmaceuticals of New York LLC.
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EMA approval · 2026-03-27EMA Authorised: Wakix (pitolisant) — Bioprojet Pharma
EMA authorised Wakix (pitolisant) for narcolepsy with Bioprojet Pharma as the marketing authorisation holder; it is designated an orphan med…
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FDA approval · 2026-03-25FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals Inc.'s supplemental application for methylphenidate hydrochloride granules (generic methylphenidate hy…
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FDA approval · 2026-02-13FDA Approved: WAKIX — Supplemental Application (Harmony Biosciences, LLC)
FDA approved a supplemental application for Wakix (pitolisant hydrochloride) from Harmony Biosciences, LLC. The action typically updates lab…
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FDA approval · 2026-01-15FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved Amneal Pharmaceuticals of New York LLC's supplemental application for methylphenidate hydrochloride.
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FDA approval · 2026-01-09FDA Approved: METHYLPHENIDATE — Supplemental Application (KVK-Tech, Inc.)
FDA granted supplemental approval for a methylphenidate hydrochloride product developed by KVK-Tech, Inc. This is a routine supplemental app…
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FDA approval · 2025-10-07FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental ANDA for methylphenidate hydrochloride by SpecGx LLC. The action formalizes a change under the generic drug appr…
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FDA approval · 2025-09-26FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma LLC)
FDA granted supplemental approval for a generic Amphetamine Sulfate product by Epic Pharma LLC.
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FDA approval · 2025-09-23FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application from Prasco Laboratories for four amphetamine salt formulations (dextroamphetamine saccharate, a…
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FDA approval · 2025-09-23FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA granted a supplemental approval for Dexedrine Spansule (dextroamphetamine sulfate) to Amneal Pharmaceuticals LLC.
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FDA approval · 2025-09-23FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate from Sandoz Inc, updating the product's approval under the existing NDA.
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FDA approval · 2025-09-23FDA Approved: METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (KVK-Tech, Inc.)
The FDA-approved supplemental application approves a generic extended-release methylphenidate hydrochloride product from KVK-Tech, Inc. for …
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FDA approval · 2025-09-10FDA Approved: SODIUM OXYBATE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved the original ANDA for sodium oxybate by Amneal Pharmaceuticals LLC, establishing a generic version of the drug. The approved in…
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EMA approval · 2025-09-05EMA Authorised: Sunosi (solriamfetol hydrochloride) — Atnahs Pharma Netherlands B.V.
Sunosi (solriamfetol hydrochloride) has been authorised in the European Union for the treatment of narcolepsy and obstructive sleep apnea; d…
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FDA approval · 2025-07-16FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Wilshire Pharmaceuticals, Inc.)
The FDA approved a supplemental application for dextroamphetamine sulfate by Wilshire Pharmaceuticals, Inc., enabling continued marketing of…
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FDA approval · 2025-06-03FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for methylphenidate hydrochloride, a generic stimulant used to treat attent…
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FDA approval · 2025-05-23FDA Approved: WAKIX — Supplemental Application (Harmony Biosciences, LLC)
FDA approved a supplemental application for WAKIX (pitolisant hydrochloride) from Harmony Biosciences, LLC.
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EMA approval · 2025-05-12EMA Authorised: Xyrem (sodium oxybate) — UCB Pharma Ltd
The European Medicines Agency authorised Xyrem (sodium oxybate) for cataplexy and narcolepsy. The marketing authorization holder is UCB Phar…
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FDA approval · 2025-04-01FDA Approved: AMPHETAMINE EXTENDED-RELEASE — Supplemental Application (Neos Therapeutics, LP)
The FDA approved a supplemental application for AMPHETAMINE EXTENDED-RELEASE from Neos Therapeutics, LP, updating the product through a supp…
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FDA approval · 2025-03-18FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for methylphenidate hydrochloride (ANDA204115), a generic ADHD medication.
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FDA approval · 2025-03-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for a generic combination of dextroamphetamine and amphetamine salts developed by Camber Pharmaceuti…
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FDA approval · 2025-03-10FDA Approved: LUMRYZ — Supplemental Application (Avadel CNS Pharmaceuticals, LLC)
FDA approved a supplemental NDA for LUMRYZ (sodium oxybate) from Avadel CNS Pharmaceuticals, LLC.
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FDA approval · 2025-03-05FDA 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…