Aurobindo Pharma gets USFDA approval for Efavirenz

Aurobindo Pharma has received approval from the USFDA for Efavirenz tablets, 600 mg. This is first generic approval given by USFDA to the company ahead of the rest of pharmaceutical industry.

According to a release issued to the BSE by Aurobindo today, Efavirenz is a key ARV in the anti-Aids therapy. This is the third ARV approval and Efavirenz represents a significant opportunity in Africas.

Efavirenz is internationally called as Sustiva, manufactured by Bristol Myers Squibb.

Efavirenz is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the Aids virus from reproducing in cells. Efavirenz is very commonly used in combination therapy.

The drug will now be available for consideration for purchase under the Presidents Emergency Plan for AIDS Relief (PEPFAR), a five-year program being run to fight HIV/AIDS pandemic. The plan for AIDS relief, which President Bush announced, currently provides $15 billion to fight the disease over 5 years with a special focus on 15 of the hardest-hit countries.

The PEPFAR plan is designed to prevent 7 million new HIV infections, treat at least 2 million HIV-infected people, and care for 10 million HIV-affected individuals, AIDS orphans and vulnerable children.