FDA Nod For Hydrochloride Injection For Severe Hypertension

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.

"Another product of our joint venture with Strides Arcolab, labetalol is an important addition to our specialty injectable portfolio and enhances our cardiovascular care offering," said Jeffrey M. Yordon, Sagent's chief executive officer founder and chairman of the board.  "Our labetalol features Sagent's proprietary PreventIV(TM) Measures labeling and packaging.  With our distinctive labeling designs and easy to read drug name and dosage information, we are striving to help reduce medication errors.  Further, labetalol HCl injection is latex-free, helping to prevent potential allergic reactions in patients and health care providers."

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® (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.

Labetalol HCl Injection is contraindicated in bronchial asthma, overt cardiac failure, greater than first degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product. Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.



Source-Medindia
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