Strides Arcolab has received US FDA approval for its ANDA to market Mesna injection, a prophylactic agent used to reduce the incidence of haemorrhagic cystitis caused by Ifosfamide chemotherapy. Mesna is the generic equivalent of Baxter International's Mesnex. Mesna injection will be available in 1 mg per 10ml multi-dose vials, offered in single packs and in packs of ten. According to 2009 IMS data, the US market for Mesna approximated US$ 12 million. The company is launching this product shortly. Shortly.
Ravi Seth, CEO – International Operations of Strides, said, “This is our second product approval in this month and the fifth for the partnership with Sagent Pharmaceuticals, Inc. We are excited by the growth prospects of our business in USA.”
Mesna is the fifth product being launched under the partnership between Strides and Sagent Pharmaceuticals wherein Strides is developing and supplying more than 25 injectable products for the US market which will be marketed by Sagent.
Sagent Pharmaceuticals, founded in 2006, is a privately held specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products.