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    [{"orgOrder":0,"company":"H. Lundbeck AS","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"DENMARK","productType":"Miscellaneous","year":"2011","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Phase IV","graph3":"H. Lundbeck AS","amount2":0,"highestDevelopmentShortName":"Ph IV","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Tablet","sponsorNew":"H. Lundbeck AS \/ Undisclosed","highestDevelopmentStatusID":"11","companyTruncated":"H. Lundbeck AS \/ Undisclosed"},{"orgOrder":0,"company":"Aurobindo Pharma Limited","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"INDIA","productType":"Miscellaneous","year":"2021","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Approved FDF","graph3":"Aurobindo Pharma Limited","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Solution","sponsorNew":"Aurobindo Pharma Limited \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Aurobindo Pharma Limited \/ Undisclosed"},{"orgOrder":0,"company":"Dr. Reddy's Laboratories","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"INDIA","productType":"Miscellaneous","year":"2021","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Approved FDF","graph3":"Dr. Reddy\\'s Laboratories","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Solution","sponsorNew":"Dr. Reddy\\'s Laboratories \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Dr. Reddy\\'s Laboratories \/ Undisclosed"},{"orgOrder":0,"company":"Zydus Lifesciences","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"INDIA","productType":"Miscellaneous","year":"2023","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Approved FDF","graph3":"Zydus Lifesciences","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Solution","sponsorNew":"Zydus Lifesciences \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Zydus Lifesciences \/ Undisclosed"},{"orgOrder":0,"company":"Granules India Limited","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"INDIA","productType":"Miscellaneous","year":"2020","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Approved FDF","graph3":"Granules India Limited","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Granules India Limited \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Granules India Limited \/ Undisclosed"},{"orgOrder":0,"company":"H. Lundbeck AS","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"DENMARK","productType":"Miscellaneous","year":"2011","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Phase IV","graph3":"H. Lundbeck AS","amount2":0,"highestDevelopmentShortName":"Ph IV","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"H. Lundbeck AS \/ Undisclosed","highestDevelopmentStatusID":"11","companyTruncated":"H. Lundbeck AS \/ Undisclosed"},{"orgOrder":0,"company":"Orphelia Pharma","sponsor":"INSERM | Hospices Civils de Lyon | National Research Agency, France","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"FRANCE","productType":"Miscellaneous","year":"2014","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Approved FDF","graph3":"Orphelia Pharma","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Orphelia Pharma \/ INSERM | Hospices Civils de Lyon | National Research Agency, France","highestDevelopmentStatusID":"15","companyTruncated":"Orphelia Pharma \/ INSERM | Hospices Civils de Lyon | National Research Agency, France"},{"orgOrder":0,"company":"Orphelia Pharma","sponsor":"Ethypharm","pharmaFlowCategory":"D","therapeuticArea":"Neurology","country":"FRANCE","productType":"Miscellaneous","year":"2021","type":"Licensing Agreement","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Approved FDF","graph3":"Orphelia Pharma","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Orphelia Pharma \/ Ethypharm","highestDevelopmentStatusID":"15","companyTruncated":"Orphelia Pharma \/ Ethypharm"},{"orgOrder":0,"company":"University of Pennsylvania","sponsor":"H. Lundbeck AS","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"U.S.A","productType":"Miscellaneous","year":"2010","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Phase IV","graph3":"University of Pennsylvania","amount2":0,"highestDevelopmentShortName":"Ph IV","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"University of Pennsylvania \/ H. Lundbeck AS","highestDevelopmentStatusID":"11","companyTruncated":"University of Pennsylvania \/ H. Lundbeck AS"},{"orgOrder":0,"company":"Pyros Pharmaceuticals","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"U.S.A","productType":"Miscellaneous","year":"2024","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Approved FDF","graph3":"Pyros Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Solution","sponsorNew":"Pyros Pharmaceuticals \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Pyros Pharmaceuticals \/ Undisclosed"},{"orgOrder":0,"company":"Pyros Pharmaceuticals","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"U.S.A","productType":"Miscellaneous","year":"2024","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Approved FDF","graph3":"Pyros Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Solution","sponsorNew":"Pyros Pharmaceuticals \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Pyros Pharmaceuticals \/ Undisclosed"},{"orgOrder":0,"company":"Pyros Pharmaceuticals","sponsor":"Bora Pharmaceuticals","pharmaFlowCategory":"D","therapeuticArea":"Neurology","country":"U.S.A","productType":"Miscellaneous","year":"2024","type":"Acquisition","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Neurology","graph2":"Approved FDF","graph3":"Pyros Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Solution","sponsorNew":"Pyros Pharmaceuticals \/ Bora Pharmaceuticals","highestDevelopmentStatusID":"15","companyTruncated":"Pyros Pharmaceuticals \/ Bora Pharmaceuticals"},{"orgOrder":0,"company":"Catalyst Pharmaceuticals","sponsor":"VA Office of Research and Development | National Institute on Drug Abuse","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Miscellaneous","year":"2011","type":"Inapplicable","leadProduct":"Vigabatrin","moa":"Gamma-amino-N-butyrate transaminase","graph1":"Psychiatry\/Psychology","graph2":"Phase II\/ Phase III","graph3":"Catalyst Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"Ph II\/III","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Catalyst Pharmaceuticals \/ VA Office of Research and Development | National Institute on Drug Abuse","highestDevelopmentStatusID":"9","companyTruncated":"Catalyst Pharmaceuticals \/ VA Office of Research and Development | National Institute on Drug Abuse"}]

    Find Clinical Drug Pipeline Developments & Deals for NCGC00024802-02

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    NCGC00024802-02

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                            01

                            Dr. Reddy's Laboratories

                            India
                            CPhI India
                            Booth #RH.E02
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                            Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Dr. Reddy's Laboratories Announces the Launch of Vigabatrin Tablets, USP in the U.S. Market

                            Details : The launch of Vigabatrin Tablets USP, 500 mg, which is therapeutic equivalent generic version of Sabril® (vigabatrin) Tablets, USP, is approved by the U.S. Food and Drug Administration (USFDA).

                            Product Name : Vigabatrin-Generic

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            February 02, 2021

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            02

                            Granules India Limited

                            India
                            CPhI India
                            Attending
                            • fda
                            • EDQM
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                            Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Granules India Limited announces approval of Vigabatrin for Oral Solution USP, 500 mg

                            Details : Generic version of vigabatrin is approved as monotherapy for pediatric patients with refractory complex partial seizures or infantile spasms 1 month to 2 years of age.

                            Product Name : Sabril-Generic

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            April 27, 2020

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            Granules India

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                            03

                            Pyros Pharmaceuticals

                            U.S.A arrow
                            AIChE Annual Meeting
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                            Pyros Pharmaceuticals

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                            AIChE Annual Meeting
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                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Study Phase : Approved FDF

                            Sponsor : Bora Pharmaceuticals

                            Deal Size : Undisclosed

                            Deal Type : Acquisition

                            DEALS_DEV arrow-down

                            Bora Expands Rare Disease Portfolio with Pyros Pharma Acquisition

                            Details : Through the acquisition of US-based Pyros, Bora will expand his pipelines by adding some candidates such as Vigafyde (vigabatrin), which is indicated for the treatment of infantile spasms.

                            Product Name : Vigafyde

                            Product Type : Miscellaneous

                            Upfront Cash : Undisclosed

                            October 25, 2024

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Highest Development Status : Approved FDF

                            Sponsor : Bora Pharmaceuticals

                            Deal Size : Undisclosed

                            Deal Type : Acquisition

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                            04

                            Pyros Pharmaceuticals

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                            AIChE Annual Meeting
                            Not Confirmed

                            Pyros Pharmaceuticals

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                            AIChE Annual Meeting
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                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Pyros Pharmaceuticals: FDA Approves VIGAFYDE as Ready-to-Use Oral Solution

                            Details : Vigafyde (vigabatrin) is approved as monotherapy for pediatric patients with refractory complex partial seizures or infantile spasms in patients 1 month to 2 years of age.

                            Product Name : Vigafyde

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            June 17, 2024

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            05

                            Pyros Pharmaceuticals

                            U.S.A arrow
                            AIChE Annual Meeting
                            Not Confirmed

                            Pyros Pharmaceuticals

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                            AIChE Annual Meeting
                            Not Confirmed
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                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Pyros Pharmaceuticals Reports Positive Outcome in European Procedure for VIGZIP™ Approval

                            Details : Vigzip (vigabatrin) is a Gamma-amino-N-butyrate transaminase inhibitor, which is indicated for the treatment of patients with infantile spasms (West's syndrome).

                            Product Name : Vigafyde

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            February 15, 2024

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            06

                            Zydus Lifesciences

                            India arrow
                            AIChE Annual Meeting
                            Not Confirmed

                            Zydus Lifesciences

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                            AIChE Annual Meeting
                            Not Confirmed
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                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Zydus Receives Final Approval from The USFDA for Vigabatrin for Oral Solution USP, 500 mg

                            Details : Vigabatrin its action as an irreversible inhibitor of γ-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous sy...

                            Product Name : Sabril-Generic

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            March 03, 2023

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            07

                            Aurobindo Pharma Limited

                            India arrow
                            AIChE Annual Meeting
                            Not Confirmed

                            Aurobindo Pharma Limited

                            India arrow
                            AIChE Annual Meeting
                            Not Confirmed
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                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Aurobindo Receives FDA Approval for Vigabatrin for Oral Solution USP, 500mg

                            Details : Aurobindo Pharma’s Vigabatrin for Oral Solution USP, 500 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Sabril for Oral Solution of Lundbeck Pharmaceuticals, LLC.

                            Product Name : Vigabatrin-Generic

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            October 30, 2021

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            08

                            Orphelia Pharma

                            France arrow
                            AIChE Annual Meeting
                            Not Confirmed

                            Orphelia Pharma

                            France arrow
                            AIChE Annual Meeting
                            Not Confirmed
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                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Study Phase : Approved FDF

                            Sponsor : Ethypharm

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            ORPHELIA, Ethypharm Sign Kigabeq® Licensing Deal for China

                            Details : Orphelia has granted Ethypharm exclusive rights under a license agreement to commercialize Kigabeq (vigabatrin) in China. Kigabeq is indicated as a first-line treatment for infantile spasms.

                            Product Name : Kigabeq

                            Product Type : Miscellaneous

                            Upfront Cash : Undisclosed

                            January 19, 2021

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Highest Development Status : Approved FDF

                            Sponsor : Ethypharm

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

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                            09

                            Orphelia Pharma

                            France arrow
                            AIChE Annual Meeting
                            Not Confirmed

                            Orphelia Pharma

                            France arrow
                            AIChE Annual Meeting
                            Not Confirmed
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                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Study Phase : Undisclosed

                            Sponsor : INSERM | Hospices Civils de Lyon | National Research Agency, France

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Ph...

                            Details : Vigabatrin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Spasms, Infantile.

                            Product Name : Undisclosed

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            August 19, 2014

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Highest Development Status : Undisclosed

                            Sponsor : INSERM | Hospices Civils de Lyon | National Research Agency, France

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            10

                            H. Lundbeck AS

                            Denmark arrow
                            AIChE Annual Meeting
                            Not Confirmed

                            H. Lundbeck AS

                            Denmark arrow
                            AIChE Annual Meeting
                            Not Confirmed
                            • fda
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                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Study Phase : Phase IV

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spa...

                            Details : Vigabatrin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Spasms, Infantile.

                            Product Name : Undisclosed

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            August 10, 2011

                            Lead Product(s) : Vigabatrin

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase IV

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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