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WISCONSIN PHARMACAL COMPANY ANNOUNCES SUBMISSION OF DATA TO THE FDA ON FEMALE CONDOM

 WISCONSIN PHARMACAL COMPANY ANNOUNCES
 SUBMISSION OF DATA TO THE FDA ON FEMALE CONDOM
 JACKSON, Wis., Aug. 3 /PRNewswire/ -- John A. Wundrock, R.Ph., president and CEO of Wisconsin Pharmacal Company, Inc. (NASDAQ: WPCI) announced that the company had submitted to the FDA the additional information regarding the Reality female condom as scheduled, on July 31, 1992. In January 1992, an FDA Advisory Panel unanimously recommended that the FDA approve the Reality female condom premarket approval application (PMA) subject to the completion of a pregnancy effectiveness study and the provision of certain additional data. Subsequent correspondence from the FDA requested additional information which was also included in this submission. The FDA has indicated that the submission would be reviewed on an accelerated basis consistent with the process applied to the original PMA submission.
 Wundrock announced that the FDA submission represented the completion of a significant step in the company's efforts to seek FDA approval of the Reality PMA. Other licensees began marketing the female condom in Switzerland earlier this year and are expected to begin marketing the product in other European countries in the near future. Wundrock indicated that the company is continuing discussions with several large companies as potential marketing partners for Reality in North America.
 -0- 8/3/92 R
 /CONTACT: John A. Wundrock, 414-677-4121 (company information), or Dr. Mary Ann Leeper, 312-280-8541 (product information)/
 (WPCI) CO: Wisconsin Pharmacal Company, Inc. ST: Wisconsin IN: MTC SU:


MA -- NY022 -- 6131 08/03/92 11:55 EDT
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Publication:PR Newswire
Date:Aug 3, 1992
Words:246
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