Aurobindo Pharma's generic version of ViiV Healthcare's Tivicay, or dolutegravir, has received tentative approval from the FDA for use as a treatment for HIV infection, as recommended by the Centers for Disease Control and Prevention and the World Health Organization. The firm expects to launch the drug in Sub-Saharan Africa later this year.
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.
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.