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Corporate - Regulatory Bodies & Rulings
Aurobindo drug gets FDA nod

Hyderabad, Sept. 26

Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Didanosine Delayed Release (enteric-coated) capsules in 125 mg, 200 mg, 250 mg and 400 mg. The drug is indicated for treatment of HIV – 1 infections in adults. It is the generic version of Bristol Myer Squibb’s Videx EC (Didanosine) delayed-release capsules. This was the 78th Abbreviated New Drug Application from USFDA for the Hyderabad-ba sed company, according to a release.

— Our Bureau

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