US FDA approves Invega Sustenna injectable formulation using Elan NanoCrystal technology
The US Food and Drug Administration has approved Janssen Pharmaceuticals" Invega Sustenna, the first monthly antipsychotic injection, for use with Elan Drug Technologies" NanoCrystal technology.
The US Food and Drug Administration has approved Janssen Pharmaceuticals" Invega Sustenna, the first monthly antipsychotic injection, for use with Elan Drug Technologies" NanoCrystal technology.
Shane Cooke, executive vice president and head of Elan Drug Technologies, said the approval of Invega Sustenna is an important milestone for the company's technology.
"Our versatile NanoCrystal technology, in this instance, allowed for a stable, low viscosity, high drug-loaded formulation in a small injection volume to be developed," he said.
The NanoCrystal technology allows for a ready-to-use monthly intramuscular depot formulation of paliperidone palmitate. The injection is administered using a small-bore needle and small-volume syringe. By applying NanoCrystal technology to paliperidone palmitate, for the first time, healthcare professionals will be able to provide patients with consistent medication for one month, potentially allowing them to improve compliance for schizophrenic patients.
Invega Sustenna is the fifth licensed product approved by the US FDA using Elan's NanoCrystal technology for various formulations.
