Attention Deficit Hyperactivity Disorder

• EMA approval · 2026-07-15
  EMA Authorised: Paxneury (guanfacine hydrochloride) — Neuraxpharm Pharmaceuticals S.L.

  The EMA has authorised Paxneury (guanfacine hydrochloride) for attention deficit disorder with hyperactivity, with Neuraxpharm Pharmaceutica…

• FDA approval · 2026-04-23
  FDA 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…

• FDA approval · 2026-04-23
  FDA Approved: MYDAYIS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for MYDAYIS, a mixed amphetamine salts product, submitted by Takeda Pharmaceuticals America, Inc…

• FDA approval · 2026-04-21
  FDA 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.

• FDA approval · 2026-04-10
  FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved Janssen's supplemental application for CONCERTA (methylphenidate hydrochloride), a long-acting stimulant for attention-defi…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2026-03-25
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals Inc.'s supplemental application for methylphenidate hydrochloride granules (generic methylphenidate hy…

• FDA approval · 2026-03-20
  FDA Approved: ATOMOXETINE HYDROCHLORIDE — Original Application (Advagen Pharma Ltd.)

  FDA approved atomoxetine hydrochloride from Advagen Pharma Ltd. under an Original Application NDA.

• FDA approval · 2026-03-18
  FDA Approved: LISDEXAMFETAMINE DIMESYLATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for lisdexamfetamine dimesylate (generic). This action approves changes to…

• FDA approval · 2026-03-10
  FDA Approved: QUILLICHEW ER — Supplemental Application (NextWave Pharmaceuticals, Inc)

  The FDA approved a supplemental application for Quillichew ER (methylphenidate hydrochloride) from NextWave Pharmaceuticals, Inc.

• FDA approval · 2026-03-09
  FDA Approved: QUILLIVANT XR — Supplemental Application (NextWave Pharmaceuticals, Inc)

  The FDA approved a supplemental NDA for QUILLIVANT XR (methylphenidate hydrochloride) by NextWave Pharmaceuticals.

• FDA approval · 2026-02-02
  FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for CONCERTA (methylphenidate hydrochloride) from Janssen Pharmaceuticals, Inc.

• EMA approval · 2026-01-16
  EMA Authorised: Intuniv (guanfacine hydrochloride) — Takeda Pharmaceuticals International AG Ireland

  EMA authorised Intuniv (guanfacine hydrochloride) for attention-deficit/hyperactivity disorder in the European Union. The marketing authoriz…

• FDA approval · 2026-01-15
  FDA 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.

• FDA approval · 2026-01-09
  FDA 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…

• EMA approval · 2025-12-19
  EMA Authorised: Tuzulby (methylphenidate hydrochloride) — Neuraxpharm Pharmaceuticals S.L.

  The EMA authorised Tuzulby (methylphenidate hydrochloride) for attention-deficit/hyperactivity disorder in the European Union, with Neuraxph…

• FDA approval · 2025-10-07
  FDA 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…

• FDA approval · 2025-09-26
  FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma LLC)

  FDA granted supplemental approval for a generic Amphetamine Sulfate product by Epic Pharma LLC.

• FDA approval · 2025-09-23
  FDA Approved: XELSTRYM — Supplemental Application (Noven Therapeutics, LLC)

  FDA approved a supplemental application for XELSTRYM (dextroamphetamine) from Noven Therapeutics, LLC. The action updates the product labeli…

• FDA approval · 2025-09-23
  FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)

  FDA approved a supplemental application for the methylphenidate transdermal system from PADAGIS US LLC.

• FDA approval · 2025-09-23
  FDA Approved: VYVANSE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Vyvanse (lisdexamfetamine dimesylate) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2025-09-23
  FDA Approved: DYANAVEL XR — Supplemental Application (NextWave Pharmaceuticals, Inc)

  FDA approved a supplemental application for DYANAVEL XR (amphetamine) submitted by NextWave Pharmaceuticals, Inc. The submission status is A…

• FDA approval · 2025-09-23
  FDA 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…

• FDA approval · 2025-09-23
  FDA Approved: AZSTARYS — Supplemental Application (Corium, LLC.)

  The FDA approved a supplemental application for AZSTARYS (serdexmethylphenidate and dexmethylphenidate) by Corium, LLC.

• FDA approval · 2025-09-23
  FDA Approved: VYVANSE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Vyvanse (lisdexamfetamine dimesylate) from Takeda Pharmaceuticals America, expanding the approve…

• FDA approval · 2025-09-23
  FDA Approved: APTENSIO XR — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for APTENSIO XR, a methylphenidate hydrochloride product from Rhodes Pharmaceuticals L.P. The ap…