Janssen-Cilag submits MAA to the European Medicines Agency for paliperidone palmitate

Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) announced that Janssen-Cilag has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for paliperidone palmitate for the treatment of Schizophrenia. Paliperidone palmitate, an investigational, once-monthly atypical antipsychotic injection, utilises Elan Drug Technologies NanoCrystal® technology.

The NanoCrystal® technology, a technology enabling the formulation of poorly water soluble compounds for all routes of administration, facilitated the development of a stable, low viscosity, high drug loaded formulation of paliperidone palmitate. The application of the NanoCrystal® technology has allowed for a ready-to-use one month duration intramuscular injectable formulation to be developed. This product was approved by the US Food and Drug Administration (FDA) earlier this year.


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