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Aurobindo Pharma gets yet another USFDA nod

It’s a year for Aurobindo Pharma we guess. It has made another milestone achievement with another USFDA approval for manufacturing and sale of 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 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.

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.

Flecainide Acetate is an anti-arrhythmic drug used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular tachycardia and paroxysmal supraventricular tachycardia). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat.

Not a month back, Aurobindo Pharma had received USFDA nod for its Azithromycin as well as Entacapone Tablets. Even the stock market seems to be celebrating the victories of Aurobindo Pharma with its share price being on the rise.

Source: inputs from PTI
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