FDA approval for KADIAN, sustained release morphine capsules, to be contract manufactured by Faulding Inc. subsidiary and marketed by Zeneca Pharmaceuticals; Drug to enter $385 million cancer pain relief market.ELIZABETH, N.J.--(BUSINESS WIRE)--July 8, 1996--KADIAN, a new, single daily dosage sustained-release morphine morphine, principal derivative of opium, which is the juice in the unripe seed pods of the opium poppy, Papaver somniferum. It was first isolated from opium in 1803 by the German pharmacist F. W. A. product to be contract manufactured by Purepac Pharmaceutical Co., a subsidiary of Faulding Inc., has been approved by the Food and Drug Administration, it was announced today by Richard F. Moldin, president and chief executive officer of Faulding Inc. The product will enter the cancer pain relief market estimated at $385 million annually and will be marketed by Zeneca Pharmaceuticals, a subsidiary of Zeneca Inc. "KADIAN provides relief for chronic moderate to severe pain, and has been demonstrated to be as effective when taken once a day as conventional morphine products taken every four hours or currently marketed controlled release morphine products taken twice a day," Moldin said. Purepac Pharmaceutical Co. will manufacture KADIAN at its facility in Elizabeth. The patented product was developed in Australia by F.H. Faulding & Co. Limited, the ultimate majority owner of Faulding Inc. KADIAN will be marketed in the U.S. by Zeneca under an exclusive distribution agreement signed early this year. The contract manufacturing arrangements with Purepac were agreed upon Adj. 1. agreed upon - constituted or contracted by stipulation or agreement; "stipulatory obligations" stipulatory noncontroversial, uncontroversial - not likely to arouse controversy prior to Faulding Inc.'s purchase in February of the U.S. operating units of F.H. Faulding. Faulding Inc., the former Purepac Inc., has recently expanded beyond generic oral drugs into potentially higher-margin injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. drugs and drug delivery devices. Faulding Inc. already has received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval for three products in 1996 and currently has 13 applications filed with the FDA. The company's shares are trading on NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on under the symbol "FAUL FAUL Federação da Área Urbana de Lisboa (Partido Socialista - Portugal) ." -0- KADIAN is a trademark of F.H. Faulding & Co. Limited. CONTACT: Faulding Inc. Lee Craker, 908/527-9100 |
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