NEW DELHI: Strides Shasun said it has received tentative approval from the US health regulator for Efavirenz tablets used in treating human immunodeficiency virus (HIV) infection.
The company has received tentative approval from the US Food and Drug Administration (USFDA) for Efavirenz tablets USP, 600 mg, Strides Shasun said in a regulatory filing.
The final approval will be received after patent expiry in August 2018, it added.
According to IMS sales data, the US market for Efavirenz tablets is around USD 150 million.
The company will manufacture the product at its oral dosage facility in Bengaluru.