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Corporate - Regulatory Bodies & Rulings
Aurobindo gets FDA nod for drug

Our Bureau

Hyderabad, March 9

Aurobindo Pharma Ltd has obtained the final approval from the US Food and Drug Administration (USFDA), for its Didanosine Oral Suspension (paediatric powder) in 10 mg/ml dosage. The product is the first general version of the research product, Videx Pediatric power for oral suspension, 10 mg/ml manufactured by Bristol Myers Squibb Pharmaceuticals, according to a company press release here today.

The company manufactures both API and formulation for this generic. Post this development, the total number of Abbreviated New Drug Application (ANDAs) approvals from the USFDA stands at 38, including 22 final and 16 tentative, the release added.

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