India's Aurobindo Pharma has submitted an abbreviated new drug application (ANDA) to the FDA for the treatment of HIV as part of the country's pharmaceutical industry's efforts to ramp up production of drugs to treat HIV/AIDS.
The application is the first ANDA application for a generic version of dolutegravir, and comes just two years after the regulatory agency approved Tivicay (dolutegravir) for sale in the U.S., Pharmabiz.com reports. If approved, the company would be able to supply 50 mg doses of the drug for countries outside the United States.
Indian pharmaceutical companies have been ramping up production of HIV/AIDS meds due to shortages of some of the drugs. The National AIDS Control Organization said last fall that India needed 7.2 million tablets a month to meet demand, and other reports pegged as many as 150,000 patients risked going without the meds by last November due to bureaucratic delays that mired the production process.
The company said in a press release that it was seeking to address the spread of HIV through the development of a newer class of drugs and fixed-dose combinations for low- and middle-income countries.
The ANDA submission comes less than 5 years after Viiv Healthcare, which was established in 2009 by GlaxoSmithKline ($GSK) and Pfizer ($PFE) to battle HIV, and the Clinton Health Access Initiative signed an agreement to bring innovative formulations for the treatment and prevention of HIV/AIDS for people living in developing countries. Both organizations support the Aurobindo application, which can help speed up the application process for the drug.
- read the Pharmbiz.com story