India's Strides Arcolab gets FDA approval to sell Adenosine injection in US
Indian pharmaceutical company Strides Arcolab on Tuesday said it got the United States Food and Drug Administration (FDA) approval to sell an additional package size of Adenosine injection used for treating cardiac diseases.
The Bangalore-based pharmaceutical company said it will launch the Adenosine, which is a generic equivalent of Astellas Pharmaceuticals’s Adenoscan, in the US market under a partnership with Sagent Pharmaceuticals.
Strides Arcolab has got FDA approval for Adenosine injection USP in the strength of 3 mg/mI packaged in 12 mg/4 ml single dose vials, it said in a filing with the Bombay Stock Exchange.
Sagent will be marketing more than 25 injectable products that are being made by Strides for the US market.
Strides Arcolab, which has already got approval for Adenosine injection in the strength of 60mg per 20 ml and 90 mg per 30 ml vials, said the US innovator market for Adenosine presentations was nearly $94 million according to September IMS data.
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