logo BDSP

Base documentaire

  1. U.S. food and Drug administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis. Author's reply.

    Article - En anglais

    In August 1997, AmBisome (liposomal amphotericin B, Nexstar, San Dimas, CA) was the first drug approved for the treatment of visceral leishmaniasis by the U.S. Food and Drug Administration.

    The growing recognition of emerging and reemerging infections warrants that safe and effective agents to treat such infections be readily available in the United States.

    The following discussion of the data submitted in support of the New Drug Application for AmBisome for the treatment of visceral leishmaniasis shows the breadth of data from clinical trials that can be appropriate to support approval for drugs to treat tropical diseases.

    Mots-clés Pascal : Leishmaniose viscérale, Leishmaniose, Protozoose, Parasitose, Infection, Chimiothérapie, Antiparasitaire, Forme pharmaceutique, Liposome, Service santé, Traitement, Acceptation, Etats Unis, Amérique du Nord, Amérique, Autorisation, Food and Drug Administration, Amphotéricine B, Indication, Homme, Composé polyénique, Réglementation

    Mots-clés Pascal anglais : Kala azar, Leishmaniasis, Protozoal disease, Parasitosis, Infection, Chemotherapy, Parasiticid, Dosage form, Liposome, Health service, Treatment, Acceptance, United States, North America, America, Licence procedure, Food and Drug Administration, Amphotericin B, Indication, Human, Polyenic compound, Regulation

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 99-0124075

    Code Inist : 002B02S06. Création : 16/11/1999.