Pharma firm Strides Arcolab today said it has received the US regulatory approval for a hypertension injection -- Labetalol Hydrochrolide (HCl).
The company announced receipt of Abbreviated New Drug Application (ANDA) approval for HCl injection in the strengths of 100 mg/20 ml and 200 mg/40 ml, Strides said in a filing to the Bombay Stock Exchange.
The company expects to launch the product shortly.
"We are pleased to announce this addition to the list of approved sterile injectable products for the US market which is another important milestone in our JV partnership with Sagent," Strides Arcolab CEO Ravi Seth said.
According to the American Heart Association, more than 70 million Americans have hypertension, or high blood pressure.
According to the IMS estimates, 2009 sales of Labetalol HCl injection in the United States approximated USD 9 million.
Labetalol is the third product launched under Stride's partnership with pharma firm Sagent. Under this joint venture partnership, Sagent and Strides Arcolab are jointly developing, supplying and marketing more than 25 injectable products for the US market.
"Labetalol HCl injection is latex-free, helps to prevent potential allergic reactions in patients and health care providers," Sagent CEO Jeffrey M Yordon said in a statement.
Shares of Strides Arcolab were trading at Rs 288.25, up 5.14 per cent over previous close on the BSE.
