Strides Arcolab announces US FDA approval of Sumatriptan Succinate Injection

Strides Arcolab Limited (Strides) today announced that the U.S. Food and Drug Administration had granted approval of Sumatriptan Succinate Injection 6 mg (base)/0.5 mL, a selective agonist for a vascular 5-hydroxytryptamine1 receptor subtype. It is used for the acute treatment of migraine attacks with or without aura and the acute treatment of cluster headache episodes.

Sumatriptan will be offered as 6 mg (base)/0.5 mL, packaged in Single-use Prefilled Syringes. The total U.S. market for Sumatriptan in 2009 approximated $ 200 million, according to IMS data, of which the market for auto-injectors using pre-filled syringes and cartridges approximated $ 182 million. Launch is expected in the near future.  Launch is expected in the near future. 

Sumatriptan 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 . 

About Sumatriptan Succinate Injection
Sumatriptan Succinate Injection is a selective 5-hydroxytryptamine1 receptor subtype agonist with no significant affinity or pharmacological activity at 5-HT2, 5-HT3 receptor subtypes or at alpha1-, alpha2-, or beta-adrenergic; dopamine1; dopamine2; muscarinic; or benzodiazepine receptors. The vascular 5-HT1 receptor subtype to which Sumatriptan binds selectively and exerts its antimigrainous effect is present on cranial arteries , on the human basilar artery and in the vasculature of the isolated dura mater of humans. In these tissues Sumatriptan activates this receptor to cause vasoconstriction, an action correlating with the relief of migraine and cluster headache.

It should not be given intravenously because of its potential to cause coronary vasospasm.

Sumatriptan Injection should not be given to patients with history, symptoms or signs of ischemic cardiac, cerebrovascular, peripheral vascular syndromes or with other significant underlying cardiovascular diseases .

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.