ViiV Healthcare has received the European Commission's approval to market the HIV drug Triumeq, a fixed-dose combination of antiviral drugs dolutegravir, abacavir and lamivudine intended for patients 12 years and older who weigh at least 40 kg. The approval was based on the results of a Phase III study that involved treatment-naive adults and a bioequivalence study that compared Triumeq with dolutegravir and abacavir/lamivudine taken as separate pills.
The FDA has approved Lupin's Abacavir Sulfate, Lamivudine and Zidovudine Tablets to be used alone or as an add-on to other antiretroviral treatments in HIV patients. The drug is a generic equivalent of ViiV Healthcare's Trizivir.
ViiV Healthcare has filed an application with the European Medicines Agency for approval to market its single-tablet regimen, a combination of abacavir, lamivudine and Tivicay, for the treatment of HIV. The filing was based on data from several late-stage trials and a bioequivalence study. The regimen has been submitted for regulatory review in the U.S.
Mylan obtained federal approval for its 324-mg quinine sulfate capsules to address uncomplicated Plasmodium falciparum malaria. The therapy is a generic formulation of Qualaquin, made by Mutual Pharmaceutical.