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DepoCyt Scheduled for Dec. 18, 1997 FDA Advisory Committee Meeting
Business Wire, Nov 10, 1997
SAN DIEGO, Calif.--(BW HealthWire)--Nov. 10, 1997--DepoTech Corp. (NASDAQ:DEPO) Monday announced that the U.S. Food and Drug Administration (FDA) has advised the company that it is currently scheduling its New Drug Application (NDA) for DepoCyt for review by the FDA's Oncologic Drug Advisory Committee (Committee) on Dec. 18, 1997.
DepoCyt is an injectable sustained-release formulation of the chemotherapeutic agent cytarabine. DepoCyt is being developed in collaboration with Chiron Corp. (NASDAQ:CHIR) in the U.S. for the treatment of neoplastic meningitis, a secondary form of cancer arising from solid tumors, leukemia and lymphomas.
DepoTech filed the NDA for the treatment of neoplastic meningitis for the solid tumor indication.
The final decision regarding marketing approval of new therapeutics resides with FDA officials subsequent to any recommendation of the Committee.
DepoTech is a drug delivery company dedicated to the development and manufacture of innovative, sustained-release therapeutic products based on DepoFoam technology.
Products are being developed to satisfy medical needs in cancer, infectious diseases, pain management and other fields.
NOTE: This release move over Business Wire Nov. 10, 1997.
This news release may contain forward-looking statements regarding programs for DepoCyt. Actual results could differ materially from those described in this news release as a result of a number of factors, including, but not limited to the following: There can be no assurance that any product in the DepoTech product pipeline will be successfully developed or manufactured, or that final results of human clinical trials will be supportive of regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of these products will be achieved. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this release.
Additional written materials and recent releases regarding DepoTech are available on the World Wide Web at http://www.depotech.com .
CONTACT: DepoTech Corp., San Diego
Edward L. Erickson, 619/625-2424
or
Chiron Corp.
Jim Knighton, 510/923-6555
or
StratiPoint Group
Mike Jackman, 415/388-3216
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