FDA: Chelsea Therapeutics, Inc. Blood Pressure Drug Should Not be Approved

Chelsea Therapeutics International Ltd.’s drug to treat a condition that can cause dizziness in people with nervous system disorders may be unsafe and shouldn’t be approved, U.S. regulators said. The company’s shares fell. The medicine, called Northera, lacks adequate data it works, Food and Drug Administration staff said today in a report. Agency advisers are set to meet Feb. 23 on whether the agency should approved the drug, chemically known as droxidopa. If so, it would be the first product marketed by the Charlotte, North Carolina-based company.