Elan Drug Technologies, a business unit of Athlone-based drugmaker Elan, has received the first approval for its formulation for the treatment of adult schizophrenia.
Late last week, Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals, announced the approval of the long-acting injectable formulation, which uses Elan’s NanoCrystal technology, by the US Food and Drug Administration.
Invega Sustenna, the first once monthly atypical antipsychotic injection, will help treat schizophrenic patients.
“The approval of Invega Sustenna is an important milestone for our NanoCrystal technology as it marks the first long-acting injectable product approved by regulatory authorities using the technology,” announced Shane Cooke, executive vice president and head of Elan Drug Technologies.
“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.”
NanoCrystal technology is a proprietary technology developed by Elan Drug Technologies through Elan Pharma International Limited and other Elan affiliates.
Invega Sustenna is the fifth licensed product approved by the US FDA using Elan’s NanoCrystal technology for various formulations.
