Aurobindo Pharma has received final approval from the US Food and Drug Administration to produce and sell Flecainide Acetate Tablets - used for regulating heart rate - in the American market.
"Aurobindo Pharma is pleased to announce that the company has received final approval USFDA to manufacture and market Flecainide Acetate Tablets USP 50 mg, 100 mg and 150 mg (ANDA 202821)," the company said in a regulatory filing. The shipment of the tablets will commence shortly.
"The approved ANDA (Abbreviated New Drug Application) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Tambocor Tablets, 50 mg, 100 mg, 150 mg," the company said.
Flecainide Acetate Tablets are an antiarrhythmic agent with an estimated market size of USD 61 million for the 12 months ending April, according to IMS.
This is the 40th ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing Oral Non-betalactam products, Aurobindo Pharma said.
Shares of Aurobindo Pharma were trading at Rs 1,459.5, up 0.58 percent at 1130 hours.
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