LusedraTreatment for Sedation
Update: Lusedra (formerly Aquavan) Now FDA Approved - December 12, 2008
MGI Pharma Announces Aquavan NDA Accepted for Review by U.S. FDA
MINNEAPOLIS--(BUSINESS WIRE)--Dec 17, 2007 - MGI Pharma, Inc., a biopharmaceutical company focused in oncology and acute care today announced that the New Drug Application (NDA) for Aquavan (fospropofol disodium) Injection was accepted for filing by the United States Food and Drug Administration (FDA). Aquavan is an investigational drug that is being studied as a sedative-hypnotic agent in patients undergoing diagnostic or therapeutic procedures.
The NDA for Aquavan was submitted to the FDA on September 27, 2007. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review of the data. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Aquavan Injection. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by July 26, 2008.
Data from phase 2 and phase 3 trials in patients undergoing colonoscopy, a phase 3 trial in patients undergoing bronchoscopy, and an open label study in patients undergoing a variety of minor surgical procedures form the foundation of the Aquavan NDA. In total, data from 21 clinical studies, including 1,611 subjects are included in the application.
About Aquavan (fospropofol disodium) Injection
Aquavan (fospropofol disodium) Injection, a proprietary water-soluble prodrug of propofol that, after intravenous injection, is rapidly converted by an enzyme (alkaline phosphatase) in the body into propofol, is a product candidate in development for sedation of patients undergoing diagnostic or therapeutic procedures. Aquavan has not been approved for marketing by the U.S. Food and Drug Administration (U.S. FDA) or any other regulatory agencies.
About MGI Pharma
MGI Pharma, Inc. is a biopharmaceutical company focused in oncology and acute care that acquires, researches, develops, and commercializes proprietary products that address the unmet needs of patients. MGI Pharma markets Aloxi (palonosetron hydrochloride) Injection, Dacogen (decitabine) for Injection, and Gliadel Wafer (polifeprosan 20 with carmustine implant) in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI Pharma, please visit www.mgipharma.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI Pharma's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause MGI Pharma's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the determinations by FDA regarding the safety or efficacy of Aquavan Injection and other risks and uncertainties detailed from time to time in MGI Pharma's filings with the Securities and Exchange Commission including its most recently filed Form 10-K and Form 10-Q. MGI Pharma undertakes no duty to update any of these forward-looking statements.
Posted: December 2007
- FDA Approves Lusedra (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation - December 15, 2008
- Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures - July 28, 2008
- MGI Pharma Announces Submission of Aquavan NDA - September 27, 2007