Aurobindo Pharma gets final USFDA nod for cholesterol drug

Aurobindo Pharma Ltd has got final approval from the US Food and Drug Administration (FDA) to manufacture and market cholesterol-lowering fenofibrate tablets in 48 milligram (mg) and 145 mg dosage forms. The approved abbreviated new drug application (ANDA) is the generic version of AbbVie Inc.’s Tricor® tablets. Fenofibrate is used to treat high levels of cholesterol and triglycerides in the blood.

  • The approved product has an estimated market size of $412 million for the 12 months ending March 2016.
  • This is the 75th ANDA to be approved out of the Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products.
  • Aurobindo now has a total of 259 ANDA approvals, including 222 final and 37 tentative approvals from FDA.
  • Shares of Aurobindo dropped 0.41% and were trading atRs.801.90 at 1.15pm, while the benchmark Sensex index declined 0.25% to 25,207.54 points.