Attention Deficit Hyperactivity Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-11-29FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for a generic extended-release dexmethylphenidate hydrochloride product (Par Health USA, LLC) for at…
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FDA approval · 2019-11-19FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for FOCALIN XR submitted by Sandoz Inc.
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FDA approval · 2019-11-19FDA Approved: FOCALIN — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for FOCALIN (dexmethylphenidate hydrochloride) from Sandoz Inc, updating the product's labeling.
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FDA label_change · 2019-11-19FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc, resulting in labeling changes for the product.
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FDA approval · 2019-11-19FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) from Novartis Pharmaceuticals Corporation.
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FDA approval · 2019-10-22FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)
The FDA approves a supplemental NDA for the methylphenidate transdermal system (patch) from Padagis US LLC, expanding the product’s approved…
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CLINICAL_TRIALS trial_result · 2019-10-14Clinical Trial Update: Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance [Phase 4]
Phase 4 trial evaluating the expectancy versus pharmacotherapy effect of Adderall on cognitive performance; results posted in 2019.
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FDA approval · 2019-10-04FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' methylphenidate hydrochloride as a generic ADHD medication under an ANDA (Original Application).
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CLINICAL_TRIALS guidance · 2019-09-27Clinical Trial Update: Communication to Improve Shared Decision-Making in ADHD [NA]
Clinical trial update describing a communication approach to improve shared decision-making in ADHD; results posted after completion.
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CLINICAL_TRIALS withdrawal · 2019-09-18Clinical Trial Update: Classroom Study of SPN-812 in Children With ADHD [Phase 3]
A Phase 3 trial of SPN-812 in children with ADHD was withdrawn.
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CLINICAL_TRIALS trial_result · 2019-09-17Clinical Trial Update: Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD [Phase 4]
Phase 4 trial assessing the effects of an evening dose of immediate-release methylphenidate on sleep in children with ADHD; study terminated…
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CLINICAL_TRIALS trial_result · 2019-09-17Clinical Trial Update: Examining Tolerance to CNS Stimulants in ADHD [Phase 4]
Phase 4 trial examining tolerance to CNS stimulants in ADHD has completed with results posted.
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FDA approval · 2019-09-13FDA Approved: MYDAYIS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for MYDAYIS submitted by Takeda, resulting in updated labeling for the ADHD medication. The supp…
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CLINICAL_TRIALS research · 2019-09-13Clinical Trial Update: New Technologies to Help Manage ADHD [NA]
A completed clinical trial update on new technologies to help manage ADHD; results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-09-11Clinical Trial Update: Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD [NA]
A completed clinical trial evaluating how stimulant medication affects emotional lability in patients with ADHD, with results posted in 2019…
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FDA approval · 2019-09-03FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (XLCare Pharmaceuticals, Inc.)
FDA approved methylphenidate hydrochloride from XLCare Pharmaceuticals, Inc. via an Original Application (ANDA) for generic methylphenidate …
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CLINICAL_TRIALS trial_result · 2019-08-13Clinical Trial Update: Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years [Phase 3]
A Phase 3 trial assessing SHP465 6.25 mg for ADHD in children aged 6-12 has completed with posted results.
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FDA approval · 2019-08-05FDA Approved: AMPHETAMINE SULFATE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals Inc.'s amphetamine sulfate as an Original Application under the ANDA212619, marking a generic product …
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FDA approval · 2019-07-30FDA Approved: GUANFACINE EXTENDED-RELEASE — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for guanfacine extended-release from Upsher-Smith Laboratories, authorizing its continued market…
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FDA approval · 2019-07-30FDA Approved: GUANFACINE — Supplemental Application (Sun Pharmaceutical Industries, Inc)
The FDA approved a supplemental application for guanfacine from Sun Pharmaceutical Industries, Inc., finalizing an updated approval for the …
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FDA approval · 2019-07-30FDA Approved: GUANFACINE EXTENDED-RELEASE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental ANDA for guanfacine extended-release (generic) to Apotex Corp., granting regulatory approval for the generic pro…
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FDA approval · 2019-07-19FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)
The FDA approved a generic dexmethylphenidate hydrochloride product from Ascend Laboratories for the treatment of attention-deficit/hyperact…
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CLINICAL_TRIALS trial_result · 2019-07-16Clinical Trial Update: PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations [Phase 2]
Phase 2 clinical trial update evaluating AEVI-001 for ADHD in children and adolescents without mGluR mutations has completed with results po…
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CLINICAL_TRIALS trial_result · 2019-07-16Clinical Trial Update: PART A: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and With mGluR Mutations [Phase 2]
Phase 2 trial update evaluating AEVI-001 in children and adolescents with ADHD and mGluR mutations has completed with results posted.
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CLINICAL_TRIALS trial_result · 2019-07-10Clinical Trial Update: Training Attentional Awareness and Control in ADHD [NA]
A completed clinical trial investigating training attentional awareness and control in ADHD; results posted in 2019.