DARA BioSciences, Inc. Announces Submission of KRN5500 to FDA for Orphan Designation
11/29/2012 9:54:31 AM
RALEIGH, N.C.--(BUSINESS WIRE)--DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today it has submitted an Orphan Drug Application to the U.S. Food and Drug Administration (FDA) for KRN5500, a compound in development to treat a painful form of chronic chemotherapy-induced peripheral neuropathy (CCIPN). The FDA provides orphan drug status to products that treat rare conditions for which there may be few adequate therapies. No approved treatments currently exist for CCIPN. Orphan designation qualifies the drug developer for tax credits, the waiver of the prescription drug user fee and seven-year market exclusivity. DARA engaged consultants with extensive FDA experience to guide the preparation of the Orphan Drug Application.