FDA needs additional information before approval of ABBV-951
The U.S. Food and Drug Administration (FDA) has requested more information about the specialized pump used to administer ABBV-951 (foslevodopa/foscarbidopa), an under-the-skin formulation of levodopa/carbidopa, before it will consider approving the therapy for motor fluctuations in people with advanced Parkinson’s disease. The agency’s complete response letter comes 10…