Aurobindo Pharma gets US FDA nod for Didanosine Oral Suspension

Saturday, March 17, 2007, 15:04 [IST]

New Delhi, Mar 11 (UNI) Aurobindo Pharma Ltd has got the US Food and Drug Administration (FDA) approval for its Didanosine Oral Suspension (Pediatric Powder) 10 mg/ml.

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, a statement said.

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.

Recently the company received a nod from NAM (National Agency for Medicines), Finland for its facility at Unit-VI to manufacture cefuroxime injectable 750mg and 1500mg.

UNI

Topics: PHARMA-AUROBINDO-USFDA APPROVAL

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