Aurobindo Pharma Ltd, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Didanosine Delayed Release (enteric-coated) capsules in 125mg, 250mg and 400mg strengths.
This is the company's 78th abbreviated new drug application (ANDA) from the USFDA.
Didanosine Delayed Release capsule is the generic version of Bristol Myer Squibb’s Videx EC and is indicated for the treatment of HIV-1 infections in adults, the company said in a press release on Thursday.