New Delhi: Strides Shasun said it has received approval from the US health regulator for its generic Efavirenz tablet used for the treatment of HIV Type-1 infected adults and adolescents.
The approval granted to the company’s wholly-owned subsidiary Strides Pharma Global Pte by the US Food and Drug Administration (USFDA) is for Efavirenz tablets of 600 mg strength, the company said in a regulatory filing.
“Strides is launching the product immediately,” it said, adding, it was only the second generic company to get the approval for the product under the para IV route giving it marketing exclusivity.
Efavirenz tablet is the generic version of Sustiva tablets of Bristol-Myers Squibb Company.
The product will be manufactured at the company’s oral dosage facility at Bangalore and will be marketed by Strides Pharma Inc in the US market, it added.
Citing IQVIA data, Strides said the US market for Efavirenz Tablets USP, 600 mg is approximately USD 115 million.
The company has 74 cumulative ANDA (abbreviated new drug application) filings with the USFDA, of which 44 ANDAs have been approved as of the date and 30 are pending approval, the filing said.