Aurobindo receives tentative FDA approval for efavirenz
This article was originally published in Scrip
Executive Summary
Aurobindo Pharmahas received tentative US FDAapproval to manufacture and market an antiretroviral, efavirenz tablets 100mg. The product is used in combination with other antiretrovirals and is indicated for the treatment of HIV infections. Earlier Aurobindo had received tentative approvals for efavirenz tablets 600mg, efavirenz capsules 50mg, 100mg and 200 mg and co-packaged lamivudine/zidovudine tablets and efavirenz tablets 150mg/300mg and 600mg. Aurobindo now has 86 ANDA approvals from the FDA comprising 61 final approvals and 25 tentative approvals.