West Pharmaceutical Says FDA Clears NovaGuard SA Safety System - Quick Facts

(RTTNews) - West Pharmaceutical Services, Inc. (WST) Tuesday said the NovaGuard SA (Staked-needle Automatic) safety system has received 510(k) clearance from the United States Food and Drug Administration.

The NovaGuard SA safety system helps reduce the risk of needlestick injuries by shielding the exposed needle of a prefilled syringe after use.

The World Health Organization estimates that each year healthcare workers incur two million accidental needlestick injuries that may result in infections with hepatitis B and C, HIV and other diseases.

Injectable drug delivery systems that incorporate a safety mechanism can significantly reduce the risk of accidental needlestick injuries.

The NovaGuard SA safety system helps protect patients and healthcare workers by shielding a syringe's exposed needle once activated. It is part of West's NovaGuard family of syringe safety technology offerings.

The safety system is suitable for prefilled ISO standard glass syringes and provides a tamper-evident needle shield feature and a safety mechanism which helps prevent pre-activation of the system.

West has increased its manufacturing capacity at its facility in France, where more than 1.5 billion similar safety systems have already been produced.

The NovaGuard SA safety system could be available for all geographic markets and commercial supply.

Currently, the NovaGuard SA safety system is commercialized with one marketed drug outside of the U.S. It is being evaluated by multiple West pharmaceutical partners.