Strides Arcolab bags its 8th US FDA clearance for sterile injectables in 2010
Strides Arcolab Limited (Strides) has bagged its eight US Food and Drug Administration approval for sterile injectables.
The company received the clearance for Vecuronium Bromide Injection. This neuromuscular blocking agent of intermediate duration is used as an adjunct to general anesthaesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Vecuronium is available in 10mg and 20 mg per vial.
Vecuronium will be offered as 10mg and 20 mg, AP-rated, sterile nonpyrogenic freeze-dried product in packages of ten. The total 2009 US market for injectable Vecuronium is estimated at around US$ 10 million, according to IMS data.
Strides is gearing up to launch this product in the next few months. It will be developed under the partnership between Strides and Akorn Inc wherein
the former is developing and supplying 22 injectable products for the US market which will be marketed by Akorn Inc for Akorn-Strides, LLC, a joint venture between Strides and Akorn Inc.
Vecuronium is a nondepolarizing neuromuscular blocking agent possessing all of the characteristic pharmacological actions of this class of drugs (curariform).