SCHAUMBURG, Ill., Feb. 8 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has received FDA approval of labetalol hydrochloride (HCl) injection, USP, commonly used to control severe hypertension. The product will be available in two vial sizes - 100 mg per 20 mL and 200 mg per 40 mL, multi-dose vials. According to the American Heart Association, more than 70 million Americans have hypertension, or high blood pressure. IMS estimates that 2009 sales of labetalol HCl injection in the United States approximated $9 million. Sagent expects to launch the product shortly.
Labetalol is the third product launched under Sagent’s partnership with Strides Arcolab. Under this joint venture partnership, Sagent and Strides Arcolab are jointly developing, supplying and marketing more than 25 injectable products for the U.S. market.
Sagent’s labetalol HCl Injection is the generic equivalent of Prometheus Laboratories’ Trandate(R) (labetalol HCl) Injection. Labetalol HCl Injection is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions that is used to control blood pressure in severe hypertension.
The package insert, which is available at www.SagentPharma.com, contains detailed information about the indication, warnings, complete side effect profile and prescribing information.
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. Sagent currently has more than 200 products in development.
About Strides Arcolab, Ltd.
The company has 14 manufacturing facilities across six 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.
Sagent Pharmaceuticals, Inc.
