Aurobindo Pharma Ltd has received final approval from the US FDA for Stavudine tablets, 30 mg and 40 mg. This is the fourth ARV ANDA approved by US FDA. The Company has already has got approval for Nevirapine, Lamivudine and Efavirenz.
Stavudine is an antiviral agent of the nucleoside analog class, which includes zidovudine (AZT), didanosine (ddl) and zalcitabine (ddC). The international brand name is Zerit and is marketed by Bristol Myers Squibb. Nucleoside analogs are thought to slow the progression of AIDS by inhibiting HIV replication. Data indicate that this class of drugs may delay the onset of AIDS symptoms in HIV-infected individuals, and may extend survival in some.
The drug will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR), a five-year programme being run to fight HIV/AIDS pandemic.