Autism Spectrum Disorder
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2011-08-24FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)
The FDA page documents a supplemental application for RISPERDAL M-TAB (risperidone) by Janssen Pharmaceuticals, typically filed to support l…
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FDA approval · 2011-08-24FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)
The FDA approved a supplemental application for risperidone from Janssen Pharmaceuticals, Inc. The approval updates the drug's labeling.
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FDA approval · 2011-08-24FDA Approved: RISPERIDONE — Original Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA's generic risperidone (ANDA201003).
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FDA approval · 2011-08-16FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Risperidone from Torrent Pharmaceuticals Limited, authorizing changes to the approved generic pr…
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FDA approval · 2011-08-09FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)
The FDA approved Amici Pharma, Inc.'s supplemental application for risperidone, authorizing a generic version of the antipsychotic under an …
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CLINICAL_TRIALS trial_result · 2011-07-20Clinical Trial Update: Early Pharmacotherapy Aimed at Neuroplasticity in Autism : Safety and Efficacy [Phase 1, Phase 2]
Completed Phase 1/Phase 2 trial evaluating a pharmacotherapy aimed at promoting neuroplasticity in autism, reporting safety and efficacy dat…
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CLINICAL_TRIALS trial_result · 2011-07-19Clinical Trial Update: Early Nutritional Intervention in Patients With Autism Spectrum Disorders [NA]
The clinical trial evaluating early nutritional intervention in autism spectrum disorders has completed.
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FDA approval · 2011-07-11FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)
FDA approves a supplemental application for Risperidone by Zydus Lifesciences Limited, confirming regulatory approval of changes to the prod…
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FDA approval · 2011-06-30FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)
FDA approved Westminster Pharmaceuticals, LLC's supplemental application for risperidone (RISPERIDONE). This action approves the generic pro…
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CLINICAL_TRIALS research · 2011-06-23Clinical Trial Update: Rehabilitation of Children With Multiple Disabilities [Phase 1]
Phase 1 rehabilitation trial for children with multiple disabilities has completed.
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CLINICAL_TRIALS research · 2011-06-22Clinical Trial Update: Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism [NA]
Completed clinical trial evaluating the effect of hyperbaric therapy on oxidative stress markers in children with autism.
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FDA approval · 2011-06-15FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)
The FDA approved Janssen Pharmaceutical, Inc.'s supplemental application for risperidone, resulting in updated labeling.
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FDA approval · 2011-06-15FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for Risperdal M-TAB (risperidone) filed by Janssen Pharmaceuticals, Inc., resulting in an updated/ex…
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FDA label_change · 2011-06-08FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)
FDA records a supplemental application for risperidone by Zydus Lifesciences Limited; specifics of the label changes are not provided in the…
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CLINICAL_TRIALS research · 2011-06-07Clinical Trial Update: Comprehensive Collection, Charting, and Communication System
A SymTrend Inc. clinical trial for autism involving a comprehensive collection, charting, and communication system; the current status is un…
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FDA approval · 2011-05-25FDA Approved: RISPERIDONE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved the original application for risperidone generic manufactured by Amneal Pharmaceuticals LLC.
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FDA approval · 2011-05-18FDA Approved: RISPERIDONE — Original Application (Chartwell RX, LLC)
FDA approves Chartwell RX, LLC's original application for a generic risperidone product (ANDA 077543). The approval enables marketing of the…
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FDA approval · 2011-04-19FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited, marking clearance to market this generic product.
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FDA approval · 2011-03-30FDA Approved: RISPERIDONE — Original Application (Natco Pharma USA LLC)
FDA approved Natco Pharma USA LLC's original ANDA for risperidone, enabling a generic version of the antipsychotic. The approval allows Natc…
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FDA approval · 2011-03-16FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)
FDA approved a supplemental application for risperidone from Jubilant Cadista Pharmaceuticals Inc., confirming continued approval of the gen…
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CLINICAL_TRIALS trial_result · 2011-03-11Clinical Trial Update: Hippotherapy to Improve the Balance of Children With Movement Disorders [NA]
A completed clinical trial evaluated hippotherapy for improving balance in children with movement disorders, including cerebral palsy, Down …
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FDA approval · 2011-03-02FDA Approved: ABILIFY — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental NDA for ABILIFY (aripiprazole) submitted by Otsuka America Pharmaceutical, Inc., to modify the product labeling …
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CLINICAL_TRIALS trial_result · 2011-02-23Clinical Trial Update: Joint Attention Intervention and Young Children With Autism [Phase 1, Phase 2]
Clinical trial update showing completion of Phase 1 and Phase 2 testing of a joint attention intervention in young children with autism.
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CLINICAL_TRIALS trial_result · 2011-01-24Clinical Trial Update: A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Children With Autistic Disorder and Other Pervasive Developmental Disorders (PDD) [Phase 3]
Phase 3 randomized trial comparing risperidone to placebo in children with autism spectrum disorder and related pervasive developmental diso…
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FDA approval · 2011-01-11FDA Approved: RISPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for risperidone filed by ANI Pharmaceuticals, Inc., indicating an update related to the product’…