South African pharmacy Aspen Pharmacare launched a triple-combination tablet on Monday to treat HIV in the country where the virus is most prevalent.
The company's new drug Emdolten is a once-a-day tablet in the form of dolutegravir, an antiretroviral medication that counteracts the drug resistance that often develops with older treatments for HIV, Aspen said.
The medicine also contains lamivudine and tenofovir disoproxil fumarate together with dolutegravir.
In May, the Health Products Regulatory Authority of South Africa and the European Medicines Agency issued a warning to advise doctors not to give dolutegravir to women who wish to become pregnant.
This followed the preliminary data from a study in Botswana, which found four cases of neural tube defects in babies born to mothers who became pregnant while taking the medication.
The medication is found in brand-name medications Tivicay and Triumeq, which are sold in GlaxoSmithKline's ViiV health care unit.
Aspen, which pioneered the development and manufacture of generic antiretrovirals (ARVs) in South Africa, said the use of dolutegravir was safe for men, women who are not children of childbearing age and women who have children who use contraceptives , adding that these groups represent more than 70% of HIV patients.
"The fact that (Emdolten) has been registered means that SAHPRA is comfortable making it public," Stapros Nicolaou, Strategic Trade Executive of Aspen, told Reuters in reference to the South African Health Products Regulatory Authority.
The company launched Aspen Stavudine, its first generic antiretroviral drug in August 2003, at a time when the country was grappling with a high rate of HIV infection.
South Africa accounts for 19% of the global number of people living with HIV, 15% of new infections and 11% of AIDS-related deaths, says the UN agency on AIDS on its website .
There is no vaccine to prevent HIV / AIDS. Current treatments only help patients control the disease, but the rapid mutation virus has proven to be a challenge for the medical community because it often develops resistance to existing medications.