July 25, 2008
Sagent Pharmaceuticals Launches Amiodarone HCl Injection, USP
SCHAUMBURG, Ill., July 25 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched amiodarone HCl injection, USP, a class III antiarrhythmic indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia -- a potentially life-threatening irregular heart beat. Sagent's amiodarone HCl injection will be available immediately in 150 mg/3 mL single dose prefilled syringes. According to IMS data, 2007 sales of injectable amiodarone in the United States were approximately $8 million. Amiodarone prefilled syringes are manufactured for Sagent by Gland Pharma.
"With our launch of the only multi-source, prefilled amiodarone syringe in the health care market, Sagent is making another essential product readily available to the emergency medicine community," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "In the emergency room, where seconds count, our product is ready-to-use -- and with enhanced labeling, easy to find on a crash cart. We are proud that our innovations to this important product, including a tamper-evident tip cap, yield safety enhancements that will potentially assist in saving patient's lives."
Amiodarone is the eighth product introduced from Sagent's pipeline of more than 200 products since the launch of the company's first product in December 2007.
Amiodarone HCl Injection, USP, is a class III antiarrhythmic indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Intravenous amiodarone can also be used to treat patients with ventricular fibrillation or ventricular tachycardia for whom oral amiodarone is indicated but who are not able to take oral medication. During or after treatment with intravenous amiodarone, patients may be transferred to oral amiodarone therapy. Intravenous amiodarone should be used for acute treatment until the patient's ventricular arrhythmias are stabilized.
The most common adverse effects may include dizziness or drowsiness; nausea, vomiting, stomach pain; insomnia; weakness, lack of coordination; or warmth, tingling or redness under the skin. Less common adverse effects include a new or worsening irregular heartbeat; wheezing, cough, chest pain, trouble breathing, coughing up blood; blurred vision, headache or pain behind the eyes; rapid weight gain; weight loss, thinning hair, increased sweating, irregular menstrual periods, swelling in the neck; numbness, burning, pain or tingling in the hands or feet; loss of appetite, dark urine, clay-colored stools, jaundice.
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. Sagent currently has more than 200 products in development.
To Discover Injectables Excellence(TM) and learn more about Sagent, please visit http://www.sagentpharma.com/.
About Gland Pharma Ltd.
Established in 1978 as an exclusive facility for Small Volume Parenterals (SVPs), Gland Pharma has developed into a progressive and quality conscious organization serving the pharmaceutical needs of more than 25 countries across the globe. Gland Pharma has world-class and world-scale facilities for injectables set up in collaboration with the Vetter Group, Germany. Gland Pharma's research and development operation develops niche products from active pharmaceutical ingredient to finished dosages. Adenosine is one of many approved abbreviated new drug applications from the Gland Pharma's growing portfolio.
For more information about Gland Pharma, please visit http://www.glandpharma.com/
Sagent Pharmaceuticals, Inc.
CONTACT: investors, Ronald E. Pauli of Sagent Pharmaceuticals, Inc.,+1-847-908-1604; or media, Rebekah Brooks of WeissComm Partners,+1-312-284-4707, for Sagent Pharmaceuticals, Inc.
Web site: http://www.sagentpharma.com/http://www.glandpharma.com/