Strides Arcolab Limited has received the US Food and Drug Administration approval for its Sumatriptan Succinate Injection 6 mg (base)/0.5 mL and Rocuronium Bromide 10mg/ml-5ml and 10 ml multi dose vials, a nondepolarizing neuromuscular blocking agent. This is the 12th approval from USFDA for the company in 2010.
While the Sumatriptan Succinate Injection is a selective agonist for a vascular 5-hydroxytryptamine1 receptor subtype, Rocuronium Bromide is used as an adjunct to general anaesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Sumatriptan Succinate Injection is used for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes. It will be offered as 6 mg (base)/0.5 mL, packaged in a single-use vial.
Rocuronium will be offered as 10mg/mL, packaged in 50mg/5mL and 100mg/10mL multi dose vials.
According to IMS data, the total US market for Sumatriptan in 2009 approximated $ 200 million, of which the market for 6 mg (base)/0.5 mL vial injection was US$ 16.2 million. The value of the US market for Rocuronium in 2009 approximated US$ 59 million .
The two injectables would be launched under the partnership between Strides and Sagent Pharmaceuticals wherein Strides is developing and supplying more than 25 injectable products for the US market which will be marketed by Sagent. The launch is expected in the near future, according to a company release.