Cipla gets US FDA approval for Generic Sustiva

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Efavirenz Tablets 600mg from the United States Food and Drug Administration (US FDA).

Cipla’s Efavirenz Tablets 600mg is AB-rated generic therapeutic equivalent version of Bristol-Myers Squibb Pharma Company’s, Sustiva. It is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in paediatric patients at least three months old and weighing at least 3.5 kg.

According to IQVIA (IMS Health), Sustiva and its generic equivalents had US sales of approximately $105M for the 12-month period ending April 2018.