WASHINGTON (Reuters) - A three-in-one AIDS pill for children was cleared on Monday by the U.S. Food and Drug Administration for use in a global U.S. AIDS relief program.
The generic pill made by India’s Cipla Ltd combines the generic HIV-fighting drugs lamivudine, stavudine and nevirapine.
This is the first pill of its kind that will be available for children under age 12 under the U.S. program.
FDA officials said the combination pill was a major advance because it can be stored, distributed and administered easily to children. The pill can be swallowed or dissolved in water.
The generic pill cannot be sold in the United States because the components are still protected by patents and available from brand-name makers. But the FDA’s tentative approval of the drug makes it eligible for purchase and use in other countries under President George W. Bush’s AIDS relief program.
The FDA also said it gave tentative approval to generic nevirapine tablets made by Hetero Drugs Ltd of India, which will also be available for the program.
Bush launched the five-year, $15 billion program in 2003 that aims to pay for treatment for 2 million AIDS sufferers and provide care for 10 million others in 15 countries, mostly in Africa.
Reporting by Lisa Richwine