Neurochem's Kiacta Granted Class 2 Review

Neurochem Limited has received an acknowledgment from the FDA that Neurochem’s response to the July approvable letter for the new drug application (NDA) for Kiacta, a treatment for Amyloid A amyloidosis, is complete.

The Prescription Drug User Fee Act date is April 2, 2008, according to Neurochem.

The Kiacta (eprodisate) NDA was filed in February 2006. The FDA said the company’s response to the second approvable letter is complete, allowing for the Class 2 review.