West Receives FDA Approval for Needle Safety System
West Pharmaceutical Services Inc. reports that its NovaGuard SA (staked-needle automatic) safety system has received 510(k) clearance from the United States Food and Drug Administration. The safety system helps reduce the risk of needlestick injuries by shielding the exposed needle of a prefilled syringe after use.
The NovaGuard SA safety system helps protect patients and healthcare workers by shielding a syringe’s exposed needle once activated. It is suitable for prefilled ISO standard glass syringes and provides a tamper-evident needle shield feature and a safety mechanism that helps to prevent pre-activation of the system. It is part of West’s NovaGuard family of syringe safety technology offerings.
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 is available for all geographic markets and commercial supply. Currently, the NovaGuard SA safety system is commercialized with one marketed drug outside of the US and is being evaluated by multiple West pharmaceutical partners, according to the company.
Source: West Pharmaceutical Services