The US Food and Drug Administration (FDA) has approved Mallinckrodt's Gablofen (baclofen injection) in prefilled syringes.
The approval forms part of the company's strategy to develop Gablofen prefilled syringe for reducing preparation steps, helping to simplify the pump refill process for patients receiving ITB Therapy (Intrathecal Baclofen Therapy) to treat severe spasticity of cerebral and spinal origin.
Gablofen prefilled syringes will be now placed in a Refill Convenience Kit, which has been re-designed to include what is needed for pump refills, according to the company which is a pharmaceuticals business of Covidien.
Mallinckrodt president Mark Trudeau said, "The prefilled syringe has the opportunity to replace the traditional glass ampules and simplify the pump refill process for healthcare providers treating appropriate patients with severe spasticity."
Developed by CNS Therapeutics, Gablofen prefilled syringes will be available in February 2013.
Gablofen is currently available in ready-to-use vials in the concentrations of 50 mcg/mL (screening dose), 500 mcg/mL, new 1,000 mcg/mL and 2,000 mcg/mL.
