ORPH receives approvable letter

Orphan Medical (ORPH) received an approvable letter from the FDA for its Xyrem sodium oxybate oral solution to treat cataplexy associated with narcolepsy. ORPH said the agency raised multiple issues in the letter, including the need for a safety update of on-going trials and data from respiratory compromised patients. ORPH also said that its contract manufacturer for Xyrem has received a GMP-related warning letter that is not related to Xyrem, but requires a re-inspection and a pre-approval inspection for Xyrem manufacturing. ORPH expects to meet the FDA's requirements this year. ...