The US Food & Drug Administration (FDA) has granted tentative approval to Strides Shasun’s HIV drug efavirenz tablet (600 mg). The final approval will be received after patent expiry in August 2018.
According to IMS data, the US market for efavirenz 600 mg tablet is approximately $ 150 million. The product will be manufactured at the company’s oral dosage facility at Bangalore and marketed by Strides in the US market.
Efavirenz tablet is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infected adults and adolescents.
