ViiV healthCare files dolutegravir for HIV treatment in EU, US and Canada
ViiV Healthcare has announced the submission of regulatory applications in the European Union , United States and Canada for the investigational integrase inhibitor dolutegravir (S/GSK1349572) for the treatment of HIV infection in adults and adolescents, specifically: -A Marketing Authorisation Application to the European Medicines Agency for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older. -A New Drug Application to the FDA for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older. -A New Drug Submission to Health Canada for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older.
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