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.
India's Aurobindo Pharma received tentative U.S. FDA approval for its generic version of GlaxoSmithKline's Ziagen Oral Solution brand of abacavir for treating pediatric AIDS patients. The tentative approval will allow the generic to become available for possible use outside the U.S. under the President's Emergency Plan for AIDS Relief.