FDA approves Sagent Pharmaceuticals' mesna injection for hemorrhagic cystitis

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced the Company has received U.S. Food and Drug Administration (FDA) approval to market mesna injection (mesna), a prophylactic agent used to reduce the incidence of hemorrhagic cystitis caused by ifosfamide chemotherapy.  

"Mesna is our second addition this month to our cancer supportive care product line, allowing Sagent's sales teams to provide customers with an expanding range of products for oncology patients," said Jeffrey M. Yordon, Sagent's chief executive officer, founder and chairman of the board.  

Mesna will be available in 1 mg per 10 mL multi-dose vials, offered in single packs and in packs of ten. According to 2009 IMS data, the U.S. market for mesna approximated $12 million. As with all Sagent products, Mesna is completely latex free and features Sagent's proprietary PreventIV Measures™ packaging and labeling.

Mesna is the fifth product approved under Sagent's joint venture with Strides Arcolab.  Under this venture, Sagent and Strides Arcolab are jointly developing, supplying and marketing more than 25 injectable products for the U.S. market.  Strides is responsible for developing and manufacturing injectable products that Sagent will market in the United States.