Aurobindo Pharma gets nod for Didanosine Delayed Release Capsules
One of the largest API manufacturers in Asia, Aurobindo Pharma Limited, has secured final approval from the US Food & Drug Administration (USFDA) to manufacture and market Didanosine Delayed Release (Enteric-Coated) Capsules 125mg, 200mg, 250mg and 400mg.
Didanosine Delayed Release Capsules is the generic version of Bristol Myer Squibb's Videx EC (Didanosine) Delayed-release Capsules and is indicated for the treatment of HIV-1 infections in combination with other antiretroviral in adults.
This is the company's 78th abbreviated new drug application (ANDA) from the USFDA.
Earlier this month, the company received tentative approval from US FDA, to manufacture and market Abacavir Sulfate or Lamivudine tablets, used in the treatment of AIDS.