Topiramate approval history

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  • More than 15 different, medium-to-large-size pharma companies were contacted, but the argument came back, time and again, that a clear-cut mechanism of

    Topiramate (Topamax) is an antiepileptic drug recently approved by the U

    Both of these medications were only available in a solid oral dosage form—topiramate as capsules, extended-release capsules, and tablets, and zonisamide

    Uses Before taking Dosage Warnings Side effects Brand names FAQ Uses for topiramate Topiramate is used alone or together with other

    announced the FDA approval of its product, Eprontia, its ready-to-use oral solution, 25

    Topiramate was initially approved in 1995 in the UK as adjunctive treatment of partial-onset seizures in adult epilepsy patients

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    The FDA has approved five medications for long-term use for weight loss, namely: orlistat, phentermine-topiramate, naltrexone-bupropion, liraglutide, and

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    Read the full prescribing information and warnings about the potential side effects and interactions of topiramate

    Taking Topamax (topiramate tablets) with valproic acid can cause low body temperature

    There are 286 drugs known to interact with topiramate, along with 8 disease interactions, and 1 alcohol/food interaction

    Topamax is eliminated from the body through the kidneys

    Approval History Of Topamax (topiramate ) Approval Indication ; 12/24/1996 Adjunctive therapy for partial onset seizures in adults ; Affiliation 1 Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities Johnson et al determine the efficacy of topiramate vs placebo as a treatment for cocaine dependence

    Approval History Of Topamax (topiramate ) Approval Indication ; 12/24/1996 Adjunctive therapy for partial onset seizures in adults ; Adults and children 10 years of age and older—At first, 50 milligrams (mg) per day, taken in 2 divided doses

    History

    Drowsiness is a common side effect and it may occasionally cause visual or metabolic disturbances

    It is not approved as monotherapy for obesity; however, patients taking it for seizures or for psychiatric disorders (eg, binge eating, borderline personality

    Despite the beneficial effects of topiramate in reducing relapse, alcohol dependence, anxiety and craving, this medication has not been approved for the treatment of alcohol dependence in either Europe or USA and needs further investigations (Michalak & Biala, 2016)

    3 Dose-controlled studies show that topiramate can be effectively used as monotherapy for seizures in both children and adults

    Topiramate (toe PYRE a mate) has been approved by the FDA as initial monotherapy for focal-onset or primary generalized tonic-clonic seizures in patients 2 years and older, and as adjunctive therapy for focal-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 Introduction

    Topamax uses can vary

    TOPAMAX for at least 6 months, according to the International Headache Society (IHS) diagnostic criteria

    The mean migraine headache frequency rate at baseline was approximately 5

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  • Topiramate approval history
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