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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-244 CHEMISTRY REVIEW(S) Memorandum to File To: NDA 22-244; Lusedra™(fospropofol disodium) Injection From: Elsbeth Chikhale, Ph.D. - Chemistry Reviewer Subject: Resubmission dated 10/13/08 (complete amendment to Not Approval Letter) Date: December 11, 2008 Applicant: MGI Pharma, Inc. Proposed Proprietary Name: LUSEDRA Established Name: fospropofol disodium Dosage form and strength: 35 mg/mL Route of Administration: intravenous Indications: use as a sedative-hypnotic agent 0\6: · Minor editorial changes were made to the CMC sections of the package insert. · The following container and carton label wer~ submitted on 10/13/08: I Page(s) Withheld Trade Secret / Confidential (b4) V Draft Labeling (b4) Draft Labeling (b5) Deliberative Process (b5) Withheld Track Number: Chemistry- If . SPL: LUSEDRA fosf)ropofol disodium injection Product Information HUMAN NDC Product Code 62856- Product Type PRESCRIPTION DRUG (Source) 350 Route of Administration INTRA VENOUS DEA Schedule bl4) INGREDIENTS Name (Active Moiety) Type Strength fospropofol disodium (fospropofol) Active 35 MILLIGRA In 1 MILLILITER monothioglycerol Inactive tromethamine Inactive Product Characteristics Color Score Shape Size