Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced FDA approval of metoprolol tartrate injection, USP (metoprolol). The AP-rated product will be sold in latex-free 5 mg per 5 mL vials that feature Sagent’s proprietary PreventIV Measures(TM) labeling and packaging. Metoprolol is commonly used in the treatment of acute myocardial infarction (AMI). According to the American Heart Association, an estimated 1.4 million people annually will suffer a heart attack or AMI. IMS data indicates 2009 sales of metoprolol approximated $13 million. Sagent expects to launch the product shortly.
“Metoprolol is the third product approved this month and an important addition to our vital cardiovascular care portfolio, which already includes adenosine pre-filled syringes and vials, amiodarone pre-filled syringes, and labetalol vials,” said Jeffrey M. Yordon, Sagent’s chief executive officer, founder, and chairman of the board. “Our collaboration with Strides continues to be an enormous success, with metoprolol marking the sixth product approved under our joint venture.”
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.