USFDA clears sale of Dr Reddy’s ovarian cancer generic drug
Dr Reddy’s has received approval from the USFDA to sell its generic version of Alza’s Doxil injection used for treatment of ovarian cancer
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New Delhi: Dr Reddy’s Laboratories (DRL) has received approval from the US health regulator to sell its generic version of Alza Corp.’s Doxil injection used for treatment of ovarian cancer.
The approval from the US Food and Drug Administration (USFDA) for doxorubicin hydrochloride liposome intravenous injection is an outcome of extensive collaboration with the company’s partner Natco Pharma on research and development and manufacturing capabilities, Dr Reddy’s said in a BSE filing.
The injection comes in single dose vials of 10 ml or 30 ml, it added.
DRL executive vice president and head of North American generics business Alok Sonig said it is the first of its kind for the company.
“We are preparing for a commercial launch soon,” he added.
The Doxil brand and generic version had sales of about $196 million in the 12 months ended March 2017, DRL said citing IMS Health data.
Shares of DRL were trading at Rs 2,743.20 apiece in the afternoon trade, up 0.74%, from the previous close on the BSE.