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APL gets FDA nod for new drugs
City-based Aurobindo Pharma Limited (APL) has received final approval from the US health regulator to manufacture and market generic version of blood pressure treatment drugs, Amlodipine and Valsartan tablets.
Hyderabad: City-based Aurobindo Pharma Limited (APL) has received final approval from the US health regulator to manufacture and market generic version of blood pressure treatment drugs, Amlodipine and Valsartan tablets.
The approval by the US Food and Drug Administration (USFDA) is for multiple strengths of 5mg/160mg, 5mg/ 320mg and 10mg/320 mg, the company said. The drug maker is likely to launch the new drugs in the first quarter of current fiscal.
The new drug is bio-equivalent and therapeutically equivalent to the reference listed product Exforge of Novartis Pharmaceuticals Corporation, it said. Citing IMS data, the company said the approved product had an estimated market size of $123 million in the 12 month period ended February 2016. This is the 71st ANDA to be approved out of Unit VII of the company's formulation facility for oral non-antibiotic products in Hyderabad.
