The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Navidea Biopharmaceuticals' Lymphoseek radiopharmaceutical agent for use in sentinel lymph node detection in patients with head and neck cancer.
The FDA's orphan drug program confers a special status on drugs and biologics intended to treat, diagnose, or prevent diseases and disorders that affect fewer than 200,000 people in the U.S., the company said.
The designation gives Navidea a seven-year marketing exclusivity period against competition in head and neck cancers, as well as incentives such as federal grants, tax credits, and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees. This will allow Navidea to request a refund of previously paid filing fees of up to $1.1 million.
