BackAurobindo Pharma gets FDA nod to launch fenofibrate tablets in US
Fenofibrate is used to treat high levels of cholesterol and triglycerides in the blood
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Hyderabad: Aurobindo Pharma Ltd on Friday said it 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.
“This product is expected to be launched in Q1 FY16-17," Aurobindo said in a statement.
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," the company said, quoting US-based healthcare information provider IMS Health.
This is the 75th ANDA to be approved out of the Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products, the company said.
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 at ₹ 801.90 at 1.15pm, while the benchmark Sensex index declined 0.25% to 25,207.54 points.
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