FDAnews Drug Daily Bulletin

The FDA has granted tentative approval for two HIV therapies made by Hetero Drugs — efavirenz 600-mg tablets and stavudine capsules 15-, 20-, 30- and 40-mg capsules.

Both therapies are generic versions of HIV drugs made by Bristol-Myers Squibb — Sustiva (efavirenz) and Zerit (stavudine) — and are for use in combination with other antiretrovirals, according to the FDA’s Office of Special Health Issues.

Hetero Drugs, which is based in India, cannot market the products in the U.S. because of existing patents or exclusivity rights. However, the drugs are eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program.

PEPFAR is a five-year, $15 billion program first announced in 2003 to combat HIV and other diseases in 114 countries. During this year’s State of the Union Address, President Bush called for an additional $30 billion commitment to the program over the next five years.