NeuroDerm Reveals Removal Of Import Alert By FDA On Infusion Pumps

NeuroDerm Ltd. NDRM disclosed the removal of FDA alert on infusion pumps used in the clinical trials ND0612. The company said it was informed by Canè S.p.A., the third party manufacturer of the infusion pumps that they were removed from the list of companies under import alert.

NeuroDerm said this was the latest regulatory action taken by the FDA on April 21. That means the normal shipments to the US from this manufacturer can now be resumed.

The company indicated this import alert was enacted in July of 2015 when Canè S.p.A was issued a Warning Letter by the regulator requesting the manufacturer to provide more documentation pertaining to good manufacturing practices of the Quality System regulation.

Now, the manufacturer's corrective actions and response to this Warning Letter were determined by the FDA to be apparently adequate, which led to the lifting of the import alert.

NeuroDerm clarified that its clinical development plan remains on track with its previously announced timelines both in the US and EU.

On Friday, the stock traded higher by 0.78 percent.