An abbreviated new drug application was submitted by Aurobindo Pharma to the FDA to introduce a generic version of dolutegravir for use as a treatment for HIV. The generic dolutegravir will be supplied by Aurobindo through the President's Emergency Plan for AIDS Relief program once it receives tentative approval from the FDA and support from local regulators.
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.