Saturday, March 10, 2007

Aurobindo Receives US FDA Final Approval For Didanosine Oral Suspension

Aurobindo Pharma Ltd has announced that the US FDA has granted final approval for the Companys 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. The Company manufactures both API and formulation for this generic.The total number of ANDA approvals from US FDA stands at 38 which includes 22 final approvals and 16 tentative approvals.

No comments: