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Sagent Pharmaceuticals Announces Two New FDA Approvals: Sumatriptan Succinate Injection and Rocuronium Bromide Injection

August 2, 2010

SCHAUMBURG, Ill., Aug. 2 /PRNewswire/ — Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced two FDA approvals — sumatriptan succinate injection and rocuronium bromide injection. Sumatriptan succinate injection (sumatriptan) will be available in 6 mg per 0.5 mL latex-free vials. Rocuronium bromide injection will be available in latex-free vials of 50 mg per 5 mL and 100 mg per 10 mL. According to 2009 IMS data, the U.S. market for injectable sumatriptan approximated $22 million and $59 million for rocuronium.

“The addition of sumatriptan and rocuronium vials further expands our portfolio of injectable products,” said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. “Migraine and cluster headaches are serious medical conditions and sumatriptan is a frequently prescribed medication for the treatment of these afflictions while rocuronium use is vital in many critical surgeries. Sumatriptan and rocuronium will include Sagent’s proprietary PreventIV Measures(TM) labeling and packaging, which can help clinicians differentiate these offerings from other products or dosages.”

Sumatriptan and rocuronium will be the eighth and ninth products approved under the Sagent and Strides Arcolab partnership. 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 supplying injectable products which Sagent markets in the United States.

About Sumatriptan for Injection

Sumatriptan for injection is the generic equivalent of GlaxoSmithKline’s Imitrex®. Sumatriptan is a vascular headache suppressant indicated for 1) the acute treatment of migraine attacks with or without aura and 2) the acute treatment of cluster headache episodes. It is not for use in the management of hemiplegic or basilar migraine.

The sumatriptan for injection package insert, which is available at www.SagentPharma.com, contains detailed information about the indication, contraindications, warnings, complete side effect profile and prescribing information.

About Rocuronium Bromide Injection

Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent indicated as an addition to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

About PreventIV Measures(TM)

PreventIV Measures(TM) 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(TM) 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 six countries with presence in more than 75 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.


Source: newswire



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