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Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Flecainide Acetate tablets tablets.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product Tambocor tablets. This is an anti arrhythmic agent with an estimated market size of $61 million for the 12 months ending April 2015, according to IMS.
"This is the 40th ANDA to be approved out of Unit VII formulation facility in Hyderabad,’’ the Hyderabad-based company said in release issued here on Friday. Aurobindo will commence the shipping of the product, shortly.
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