Elan Drug Gets Approval For Injectable Formulation Using NanoCrystal Technology

Elan Drug Technologies, a business unit of Elan Corporation, has announced the first approval of an injectable formulation using its proprietary NanoCrystal technology.

The company said that earlier last week, Janssen received the approval of INVEGA SUSTENNA, the first once monthly atypical antipsychotic injection, by the FDA.

Shane Cooke, executive vice president and head of Elan Drug Technologies, said: “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. 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.”

The NanoCrystal technology enables the formulation of poorly water soluble compounds for all routes of administration. It allows for a ready-to-use one month duration intramuscular depot formulation of paliperidone palmitate, said the company.

The technology was developed by the company through Elan Pharma International and other Elan affiliates. INVEGA SUSTENNA is the fifth licensed product approved by the FDA using Elan’s NanoCrystal technology.