ADHD

RegulatoryAugust 6, 2026

Impax Labs' ANDA076852 for Amphetamine Products Receives AP Status

Impax Labs' ANDA076852 for a combination of amphetamine products has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryAugust 1, 2026

FDA Approves Supplement for Methylphenidate by Mylan Tech Viatris

The FDA has approved a supplemental application for Methylphenidate submitted by Mylan Tech Viatris.

RegulatoryAugust 1, 2026

FDA Approval Process Update for Methylphenidate Hydrochloride by Rising

The FDA has accepted the supplemental application ANDA205756 for Methylphenidate Hydrochloride submitted by Rising.

RegulatoryJuly 31, 2026

FDA Grants Abbreviated Approval for Dextroamphetamine Combination Products

The FDA has granted abbreviated approval for ANDA211547, a combination of dextroamphetamine and amphetamine salts.

RegulatoryJuly 30, 2026

FDA Grants Priority Review for Otsuka's Simtriyo (Centanafadine)

The FDA has granted priority review status for Otsuka Pharmaceutical's NDA for Simtriyo, containing centanafadine.

RegulatoryJuly 29, 2026

FDA Grants Priority Review for Otsuka's Simtriyo (Centanafadine)

The FDA has granted priority review status for Otsuka's NDA for Simtriyo, an ADHD treatment containing centanafadine.

RegulatoryJuly 29, 2026

FDA Accepts Supplement for Vyvanse (NDA 208510) from Takeda

The FDA has accepted a supplemental application for Vyvanse (lisdexamfetamine dimesylate) from Takeda Pharmaceuticals.

RegulatoryJuly 29, 2026

FDA Accepts Supplemental Application for Vyvanse by Takeda

The FDA has accepted a supplemental application for Vyvanse (lisdexamfetamine dimesylate) submitted by Takeda Pharmaceuticals.

RegulatoryJuly 29, 2026

FDA Submission Update for Adderall XR 10 by Takeda

Takeda Pharmaceuticals has submitted a supplemental application for Adderall XR 10 (NDA021303) with a standard review priority.

RegulatoryJuly 28, 2026

FDA Accepts Supplement for MYDAYIS by Takeda

The FDA has accepted a supplemental application for MYDAYIS, a medication for ADHD, from Takeda Pharmaceuticals.

RegulatoryJuly 28, 2026

Impax Labs receives FDA approval for Methylphenidate Hydrochloride supplement

Impax Labs has received an Abbreviated New Drug Application (ANDA) approval for a supplement related to Methylphenidate Hydrochloride.

ClinicalJuly 27, 2026

Study on CBT-I Efficacy in Adolescents with ADHD Initiated

A new study is evaluating the efficacy of Cognitive-Behavioral Therapy for Insomnia (CBT-I) in adolescents with ADHD, addressing comorbid insomnia.

RegulatoryJuly 26, 2026

FDA Accepts Supplemental NDA for Concerta by Janssen Pharmaceuticals

The FDA has accepted a supplemental NDA for Concerta, a medication containing methylphenidate hydrochloride, submitted by Janssen Pharmaceuticals.

StrategyJuly 25, 2026

FDA Grants Approval for Methylphenidate Hydrochloride ANDA206932

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Methylphenidate Hydrochloride submitted by ABHAI LLC.

RegulatoryJuly 24, 2026

Hikma's Lisdexamfetamine Dimesylate Supplement Receives FDA Acceptance

The FDA has accepted Hikma's supplemental application for Lisdexamfetamine Dimesylate.

RegulatoryJuly 21, 2026

Manufacturing Issue with Xaggitin XL Tablets Reported by Martindale Pharma

A manufacturing defect has been reported for Xaggitin XL Prolonged-release Tablets, affecting tablet counts in multiple batches.

RegulatoryJuly 19, 2026

Granules' ANDA217027 for Amphetamine Products Receives FDA Approval

The FDA has approved ANDA217027 submitted by Granules for a combination of amphetamine products.

RegulatoryJuly 15, 2026

FDA Accepts Supplement for XELSTRYM by Noven Pharmaceuticals

The FDA has accepted a supplemental application for XELSTRYM, an ADHD treatment containing dextroamphetamine.

ClinicalJuly 11, 2026

Study on Integrating Behavioral Therapy in Primary Care for ADHD in Underserved Children

A study is evaluating the integration of behavioral therapy into primary care for children with ADHD from low-income backgrounds.

StrategyJuly 11, 2026

FDA Grants Approval for Methylphenidate Hydrochloride ANDA205756

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Methylphenidate Hydrochloride submitted by RISING.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for Strattera by Lilly

The FDA has approved a supplemental application for Strattera (atomoxetine hydrochloride) submitted by Lilly.

RegulatoryJuly 8, 2026

FDA Grants AP Status for Dextroamphetamine and Amphetamine Combination Products

The FDA has granted approval status (AP) for ANDA211547, a combination of dextroamphetamine and amphetamine products.

RegulatoryJuly 5, 2026

FDA Accepts Supplement Application for VYVANSE by Takeda

The FDA has accepted a supplemental application for VYVANSE, an ADHD treatment, submitted by Takeda.

RegulatoryJuly 5, 2026

Impax Labs Receives AP for Methylphenidate Hydrochloride ANDA205105

Impax Labs has received an Abbreviated Approval (AP) for its ANDA205105 application for Methylphenidate Hydrochloride.

StrategyJune 23, 2026

FDA Grants Approval for Atomoxetine Hydrochloride ANDA218875

The FDA has granted approval for ANDA218875, a generic version of Atomoxetine Hydrochloride by Creekwood Pharmaceuticals.

ClinicalJune 19, 2026

Study on Cardiovascular Abnormalities in Children with ADHD Launched

A new study has been initiated to assess the prevalence and types of cardiovascular abnormalities in children diagnosed with ADHD.

RegulatoryJune 9, 2026

FDA Accepts Supplemental Application for Concerta by Janssen

The FDA has accepted a supplemental application for Concerta, a medication containing methylphenidate hydrochloride.

Companies

Assets

Recent signals(27)

Impax Labs' ANDA076852 for Amphetamine Products Receives AP Status

FDA Approves Supplement for Methylphenidate by Mylan Tech Viatris

FDA Approval Process Update for Methylphenidate Hydrochloride by Rising

FDA Grants Abbreviated Approval for Dextroamphetamine Combination Products

FDA Grants Priority Review for Otsuka's Simtriyo (Centanafadine)

FDA Grants Priority Review for Otsuka's Simtriyo (Centanafadine)

FDA Accepts Supplement for Vyvanse (NDA 208510) from Takeda

FDA Accepts Supplemental Application for Vyvanse by Takeda

FDA Submission Update for Adderall XR 10 by Takeda

FDA Accepts Supplement for MYDAYIS by Takeda

Impax Labs receives FDA approval for Methylphenidate Hydrochloride supplement

Study on CBT-I Efficacy in Adolescents with ADHD Initiated

FDA Accepts Supplemental NDA for Concerta by Janssen Pharmaceuticals

FDA Grants Approval for Methylphenidate Hydrochloride ANDA206932

Hikma's Lisdexamfetamine Dimesylate Supplement Receives FDA Acceptance

Manufacturing Issue with Xaggitin XL Tablets Reported by Martindale Pharma

Granules' ANDA217027 for Amphetamine Products Receives FDA Approval

FDA Accepts Supplement for XELSTRYM by Noven Pharmaceuticals

Study on Integrating Behavioral Therapy in Primary Care for ADHD in Underserved Children

FDA Grants Approval for Methylphenidate Hydrochloride ANDA205756

FDA Approves Supplemental Application for Strattera by Lilly

FDA Grants AP Status for Dextroamphetamine and Amphetamine Combination Products

FDA Accepts Supplement Application for VYVANSE by Takeda

Impax Labs Receives AP for Methylphenidate Hydrochloride ANDA205105

FDA Grants Approval for Atomoxetine Hydrochloride ANDA218875

Study on Cardiovascular Abnormalities in Children with ADHD Launched

FDA Accepts Supplemental Application for Concerta by Janssen

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