Attention Deficit Hyperactivity Disorder

• CLINICAL_TRIALS trial_result · 2021-03-18
  Clinical Trial Update: Dasotraline Pediatric ADHD Study [Phase 2, Phase 3]

  Clinical trial update for dasotraline in pediatric ADHD shows completion across Phase 2 and Phase 3.

• CLINICAL_TRIALS trial_result · 2021-03-16
  Clinical Trial Update: Clinical and Pharmacogenetic Study of Attention Deficit With Hyperactivity Disorder (ADHD) [Phase 4]

  Phase 4 clinical and pharmacogenetic study of Attention Deficit Hyperactivity Disorder has completed.

• FDA approval · 2021-03-11
  FDA Approved: ATOMOXETINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for atomoxetine, enabling the marketing of a generic atomoxetine product.

• FDA approval · 2021-03-09
  FDA Approved: ATOMOXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application from Apotex Corp. to market a generic atomoxetine hydrochloride product.

• CLINICAL_TRIALS trial_result · 2021-03-05
  Clinical Trial Update: Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder [Phase 3]

  Phase 3 safety and tolerability study of SPD489 in preschool children with ADHD has completed with posted results.

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• FDA approval · 2021-03-03
  FDA Approved: GUANFACINE HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a generic formulation of guanfacine hydrochloride under an Original Application (ANDA 214689) for Unichem Pharmaceuticals (USA)…

• FDA approval · 2021-03-02
  FDA Approved: AZSTARYS — Original Application (Corium, LLC.)

  The FDA approved AZSTARYS, a once-daily ADHD medication containing serdexmethylphenidate and dexmethylphenidate, from Corium, LLC, under an …

• FDA approval · 2021-02-18
  FDA Approved: ATOMOXETINE — Original Application (Strides Pharma Science Limited)

  FDA approved an original application for generic atomoxetine by Strides Pharma Science Limited, enabling generic atomoxetine products in the…

• CLINICAL_TRIALS trial_result · 2021-02-11
  Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD) [Phase 2]

  Phase 2 trial assessing SPN-810 as adjunctive therapy for impulsive aggression in children with ADHD, completed.

• CLINICAL_TRIALS trial_result · 2021-02-10
  Clinical Trial Update: A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD [Phase 3]

  Phase 3 trial evaluating HLD200 for efficacy and safety in children with ADHD has completed and results posted.

• FDA approval · 2021-01-29
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Ascent Pharmaceuticals, Inc.)

  FDA approved a generic methylphenidate hydrochloride product under an Original Application (ANDA 207417) from Ascent Pharmaceuticals, Inc. f…

• FDA approval · 2021-01-22
  FDA Approved: AMPHETAMINE SULFATE — Original Application (SpecGx LLC)

  FDA approved the Original Application for amphetamine sulfate as a generic drug, filed by SpecGx LLC.

• FDA approval · 2021-01-13
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Rhodes Pharmaceuticals L.P.)

  FDA approves Rhodes Pharmaceuticals' original ANDA for a four-salt generic amphetamine product indicated for attention-deficit/hyperactivity…

• CLINICAL_TRIALS trial_result · 2021-01-12
  Clinical Trial Update: Large-scale Brain Organization During Cognitive Control in ADHD [Phase 4]

  Phase 4 trial in ADHD investigating large-scale brain organization during cognitive control has completed with results posted in 2021.

• FDA approval · 2020-11-25
  FDA Approved: GUANFACINE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved Slate Run Pharmaceuticals’ guanfacine as a generic product via an Original Application (ANDA213428).

• CLINICAL_TRIALS trial_result · 2020-11-17
  Clinical Trial Update: Intervening Early With Neglected Children [Phase 1, Phase 2]

  A mixed Phase 1/Phase 2 clinical trial update titled Intervening Early With Neglected Children investigating Conduct Disorder and ADHD (with…

• FDA approval · 2020-10-29
  FDA Approved: GUANFACINE EXTENDED-RELEASE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for guanfacine extended-release by Apotex Corp., enabling a generic version of the ADHD medication.

• CLINICAL_TRIALS trial_result · 2020-10-29
  Clinical Trial Update: Essential Fatty Acids in Adult ADHD [Phase 3]

  Phase 3 trial update on essential fatty acids for adult ADHD has completed.

• FDA approval · 2020-10-28
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Accord Healthcare, Inc.)

  The FDA approved Accord Healthcare's generic methylphenidate hydrochloride under Original Application (ANDA213936) for the treatment of atte…

• FDA approval · 2020-10-27
  FDA Approved: AMPHETAMINE SULFATE — Original Application (Epic Pharma LLC)

  FDA approved the Original Application for amphetamine sulfate as a generic drug manufactured by Epic Pharma LLC (ANDA 213980).

• CLINICAL_TRIALS trial_result · 2020-10-19
  Clinical Trial Update: Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder [Phase 2]

  Phase 2 trial investigating prevention of comorbid depression and obesity in adults with ADHD; completed.

• CLINICAL_TRIALS trial_result · 2020-09-24
  Clinical Trial Update: Food Additives Effects on EEG Profiles in College Students With ADHD [NA]

  A completed clinical trial studying the effects of food additives on EEG profiles in college students with ADHD; results posted in 2020.

• FDA approval · 2020-09-09
  FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved the original application for Dexmethylphenidate hydrochloride from Granules Pharmaceuticals Inc., adding a generic option for t…

• CLINICAL_TRIALS trial_result · 2020-09-01
  Clinical Trial Update: Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD [NA]

  A completed randomized double-blind clinical trial evaluating neurofeedback for attention-deficit/hyperactivity disorder has posted results.

• CLINICAL_TRIALS trial_result · 2020-08-26
  Clinical Trial Update: TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD) [Phase 3]

  Phase 3 trial update for TRI102 in children with ADHD has completed and results posted in 2020.