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TAP PHARMACEUTICAL PRODUCTS INC. WITHDRAWS NDA FOR UPRIMAŽ (APOMORPHINE HCL TABLETS) SUBLINGUAL
LAKE FOREST, Ill., June 30, 2000 - TAP Pharmaceutical Products Inc. announced today that it has withdrawn the New Drug Application (NDA) for UPRIMAŽ (apomorphine HCl tablets) for erectile dysfunction (ED), which was submitted to the U.S. Food and Drug Administration (FDA) June 30, 1999. TAP is withdrawing the NDA because it has additional data and ongoing studies that could further establish the drug's safety and efficacy profile. TAP will continue to work closely with the FDA, and will resubmit the NDA at a later date.
"TAP is very committed to patient care, and it is our hope that by taking the extra time to submit additional data, TAP will be able to provide a treatment with an even stronger product profile for men with ED," says Thomas Watkins, president, TAP.
Apomorphine HCl sublingual tablets for erectile dysfunction were licensed to TAP from Pentech Pharmaceuticals, Inc. based in Deerfield, Illinois.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint venture between Abbott Laboratories, headquartered in Abbott Park, Ill., and Takeda Chemical Industries, Ltd. of Osaka, Japan.
For more information about TAP, visit www.tap.com.
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