Strides announces US FDA approval of Rocuronium Bromide Injection

Twelfth sterile injectables approval in 2010

Strides Arcolab Limited (Strides) today announced that the U.S. Food and Drug Administration has granted approval of Rocuronium Bromide 10mg/ml-5ml and 10 ml multi dose vials, a nondepolarizing neuromuscular blocking agent. It is used as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Rocuronium will be offered as 10mg/mL, packaged in 50mg/5mL and 100mg/10mL multi dose vials. According to IMS data, the total U.S. market for Rocuronium in 2009 approximated US$ 59 million .

Rocuronium will be launched under the partnership between Strides and Sagent Pharmaceuticals wherein Strides is developing and supplying more than 25 injectable products for the U.S. market which will be marketed by Sagent. The launch is expected in the near future. 

About Rocuronium Bromide Injection
Rocuronium Bromide Injection is a non-depolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. It is used as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. It acts by competing for cholinergic receptors at the motor endplate. This action is antagonised by acetylcholinesterase inhibitors such as neostigmine and edrophonium. It is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to Rocuronium Bromide or other neuromuscular blocking agents.

About Strides Arcolab Limited:
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 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.

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™ and learn more about Sagent, please visit www.SagentPharma.com.