Aurobindo Pharma gets US FDA approval for Didanosine Oral Suspension

Saturday, March 17, 2007, 20:11 [IST]

New Delhi, Mar 9 (UNI) Aurobindo Pharma Ltd today said its Didanosine Oral Suspension (Pediatric Powder) 10 mg/ml has got the US Food and Drug Administration (FDA) approval.

This product is the first generic version of the research product, Videx Pediatric Powder for Oral Suspension, 10-mg/ml, manufactured by Bristol Myers Squibb Pharmaceuticals.

The company manufactures both API and formulation for this generic.

The total number of Abbreviated New Drug Approvals (ANDA) from US FDA stands at 38 which includes 22 final approvals and 16 tentative approvals.

UNI

Topics: PHARMA-AUROBINDO-USFDA APPROVAL

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