Attention Deficit Hyperactivity Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-09-23FDA Approved: COTEMPLA XR-ODT — Supplemental Application (Neos Therapeutics Brands, LLC)
FDA approved a supplemental application for Cotempla XR-ODT (methylphenidate) from Neos Therapeutics Brands, LLC, expanding or updating the …
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FDA approval · 2025-09-23FDA Approved: QUILLIVANT XR — Supplemental Application (NextWave Pharmaceuticals, Inc)
The FDA approved a supplemental application for Quillivant XR (methylphenidate hydrochloride) from NextWave Pharmaceuticals, Inc.
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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: QUILLICHEW ER — Supplemental Application (NextWave Pharmaceuticals, Inc)
FDA approved a supplemental application for Quillichew ER (methylphenidate hydrochloride) submitted by NextWave Pharmaceuticals, Inc.
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FDA approval · 2025-09-23FDA Approved: AMPHETAMINE EXTENDED-RELEASE — Supplemental Application (Neos Therapeutics, LP)
FDA approved a supplemental application for AMPHETAMINE EXTENDED-RELEASE from Neos Therapeutics, LP, indicating updated labeling/indication …
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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: DYANAVEL XR — Supplemental Application (NextWave Pharmaceuticals, Inc)
The FDA approved a supplemental application for DYANAVEL XR (amphetamine) by NextWave Pharmaceuticals, expanding the approved use under the …
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FDA approval · 2025-09-23FDA Approved: JORNAY PM EXTENDED-RELEASE — Supplemental Application (Ironshore Pharmaceuticals Inc.)
The FDA approved a supplemental application for Jornay PM Extended-Release (methylphenidate hydrochloride) by Ironshore Pharmaceuticals.
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FDA approval · 2025-09-23FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for FOCALIN XR (dexmethylphenidate hydrochloride) from Sandoz Inc.
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FDA approval · 2025-09-23FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved Janssen's supplemental application for CONCERTA (methylphenidate hydrochloride), a long-acting ADHD medication.
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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 · 2025-07-16FDA 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 · 2025-06-16FDA Approved: ARYNTA — Original Application (Azurity Pharmaceuticals, Inc.)
FDA approved ARYNTA (lisdexamfetamine dimesylate oral) from Azurity Pharmaceuticals under an Original Application NDA. This entry documents …
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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 · 2025-04-15FDA Approved: GUANFACINE — Original Application (Advagen Pharma Limited)
The FDA approved Advagen Pharma Limited's generic guanfacine under an original ANDA.
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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 · 2025-03-28FDA Approved: METHAMPHETAMINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methamphetamine hydrochloride from Hikma Pharmaceuticals USA Inc., validating an approved change…
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FDA approval · 2025-03-28FDA Approved: AMPHETAMINE EXTENDED-RELEASE — Supplemental Application (Neos Therapeutics, LP)
The FDA granted a supplemental approval for AMPHETAMINE EXTENDED-RELEASE from Neos Therapeutics, LP.
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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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EMA approval · 2025-03-11EMA Authorised: Paxneury (guanfacine hydrochloride) — Neuraxpharm Pharmaceuticals S.L.
The European Medicines Agency authorised Paxneury, containing guanfacine hydrochloride, by Neuraxpharm Pharmaceuticals S.L. for attention-de…
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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…
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FDA approval · 2025-02-12FDA Approved: GUANFACINE EXTENDED-RELEASE — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for guanfacine extended-release from Upsher-Smith Laboratories, adding an extended-release generic o…
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FDA approval · 2025-01-29FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' supplemental application for methylphenidate hydrochloride, a generic stimulant used to treat attention-de…
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FDA approval · 2025-01-29FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals' lisdexamfetamine dimesylate as a generic drug (Original Application) with indications for attention-d…