Sagent Pharmaceuticals Announces FDA Approval of Metoprolol Tartrate Injection, USP

SCHAUMBURG, Ill., April 21 /PRNewswire/ -- 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™ 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.

About Metoprolol Tartrate Injection, USP

Metoprolol is the generic equivalent of Novartis Pharmaceutical Corporation's Lopressor® (metoprolol tartrate injection, USP). Metoprolol is a selective beta1-adrenoreceptor blocking agent that is indicated in the treatment of hemodynamically stable patients with definite or suspected AMI to reduce cardiovascular mortality.  Treatment with intravenous metoprolol can be initiated as soon as the patient's clinical condition allows. Alternatively, treatment can begin within 3 to 10 days of the acute event.

Metoprolol is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure. It is further contraindicated in patients with a heart rate < 45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval = 0.24 sec); systolic blood pressure < 100 mmHg; or moderate-to-severe cardiac failure.

The metoprolol package insert, available at www.SagentPharma.com, contains complete prescribing information, including detailed information regarding the indication and side effect profile.

About PreventIV Measures™

PreventIV Measures™ is Sagent's comprehensive, user-driven and patient-centered approach to product labeling and packaging that is designed to help prevent medication errors. It incorporates unique label and carton designs, cap and label colors, bar coding and other features that are designed to make it easier to differentiate drugs and identify the correct dose.

About Sagent Pharmaceuticals, Inc.

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.  Sagent has created a unique, global network of resources, comprised of rapid development capabilities, sophisticated manufacturing and innovative drug-delivery technologies, quickly yielding an extensive portfolio of pharmaceutical products that fulfills the evolving needs of patients.  

To Discover Injectables Excellence™ and learn more about Sagent, please visit www.SagentPharma.com.  

About Strides Arcolab, Ltd.

Strides Arcolab, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.

The company has 14 manufacturing facilities across 6 countries, including its joint venture with Aspen in India and has a marketing presence in more than 60 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.

Additional information is available at the company's website at www.stridesarco.com.

SOURCE Sagent Pharmaceuticals, Inc.