Dr Reddy's, Sun Pharma get US regulator nod for heart disease drug
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Drug firms Dr Reddy's Laboratories, Sun Pharma and Aurobindo Pharma on Friday said they have received US health regulator's approval to sell generic Plavix, used in treating heart diseases, in the US market.
Dr Reddy's said it has launched clopidogrel tablets in the American market on Friday after receiving approval from the US Food and Drug Administration (USFDA).
Clopidogrel tablets are the generic version of Sanofi Aventis' Plavix tablets.
Dr Reddy's has received approval for tablets in strengths of 75 mg and 300 mg, while Aurobindo Pharma and Sun Pharma have received USFDA's approval for the tablets in 75 mg strength.
According to IMS Health sales data, clopidogrel tablets had sales of around $6.74 billion in the US market for the twelve months ended March 2012.
Dr Reddy's said its 300 mg clopidogrel tablets have been awarded 180-days of marketing exclusivity in the US market.
The company said its product in 75 mg strength is available in bottle count sizes of 30, 90 and 500, while 300 mg strength drug is available in blister packs of 30.
Clopidogrel tablets fall under the cardio-vascular therapeutic segment and are recommended for the prevention of various heart ailments, including peripheral arterial disease.
