FDA Advisory Committee recommends approval for ZINECARD®

Business Wire, Dec 12, 1994

DUBLIN, Ohio--(BUSINESS WIRE)--Dec. 12, 1994--The U.S. Food and Drug Administration Oncologic Advisory Committee met today to review data concerning ZINECARD(R) (dexrazoxane for injection) sponsored by Pharmacia Inc.

Based upon the data presented, the Committee members voted eight in favor and one against to recommend that ZINECARD(R) be approved under the accelerated approval mechanism. ZINECARD would be indicated for women with metastatic breast cancer who have received at least 300 mg/m2 of doxorubicin.

Pharmacia will work with FDA to facilitate the approval of ZINECARD. The FDA is not required to follow the advice of its Advisory Committees.

"We are delighted that the Advisory Committee has given their approval to the use of ZINECARD," said Fernando C. da Costa, president of Pharmacia Inc. "We believe that ZINECARD will prove to be an important contribution to the field of oncology research."

Pharmacia worldwide has approximately 20,000 employees. It ranks as one of the 20 largest pharmaceutical companies. Oncology is one of its principal research areas along with growth hormone deficiency, ophthalmic surgery, clinical nitrition (nutrients and nutrient delivery), allergy diagnostics, smoking cessation and biotechnological equipment.

CONTACT: Pharmacia Inc., Dublin

             Bethany Beck, 614/764-8162
                        or
             Burson-Marsteller, New York
             Trina Chiara, 212/614-4745