Mumbai: Strides Arcolab Ltd said on Monday it has received US FDA approval for mesna injection, an abbreviated new drug application (ANDA).
Mesna injections are used to reduce the incidence of hemorrhagic cystitis caused by chemotherapy, the company said in a statement to the stock exchange.
The US market for mesna injections is about $12 million annually and the product would be launched soon in partnership with Sagent Pharmaceuticals, it said.
Strides and Sagent have entered into a partnership wherein the former is developing and supplying more than 25 injectable products for the US market, the statement said.
Mesna injection is a generic equivalent of Baxter International Inc’s Mesnex, the statement said.
At 2:29 pm shares of Strides Arcolab were trading at Rs338.30, down 1.04% in a Mumbai market that was down 1.14%.