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`2004 > FDA Approves New Indication for Taxotere -- Prostate Cancer
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`FDA NEWS RELEASE
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`FOR IMMEDIATE RELEASE
`P04-55
`May 19, 2004
`
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`FDA
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`FDA Approves New Indication for Taxotere -- Prostate Cancer
`
`Today the Food and Drug Administration (FDA) approved Taxotere (docetaxel), injection in combination
`with prednisone ( a steroid), for the treatment of patients with advanced metastatic prostate cancer. This
`is the first drug approved for hormone refractory prostate cancer that has shown a survival benefit.
`
`“We consider this approval an important advance in the treatment of prostate cancer because it can help
`some patients live longer. Patients need as many effective treatment options as possible and Taxotere, in
`combination with prednisone, offers hope to certain patients who have not responded to other treatments,
`said Dr. Lester M. Crawford, Acting FDA Commissioner.
`
`Prostate cancer is the second leading cause of cancer death in men and for those patients who have not
`responded to hormone therapy, Taxotere, in combination with prednisone, is a new treatment option that
`has now shown a survival advantage.
`
`Taxotere works by inhibiting tubulin, a protein essential to cell division, thus preventing cancer cells from
`dividing and growing in number.
`
`The safety and effectivness of Taxotere was established in a randomized, multi-center global clinical trial
`with over 1,000 patients comparing chemotherapy with taxotere and prednisone to mitoxantrone and
`prednisone in men with metastatic, hormone—refractory prostate cancer. Taxotere, in combination with
`prednisone, given every three weeks showed a survival advantage of approximately 2.5 months over the
`control group in the trial.
`
`The most common adverse events reported were nausea, alopecia (hair loss), and bone marrow
`suppression. In addition, fluid retention and peripheral neuropathy (tingling sensations in the extremities)
`known effects of taxotere, were also observed.
`
`The American Cancer Society estimates there will be about 230,900 new cases of prostate cancer in the
`United States in 2004. About 29,900 men will die of this disease this year alone.
`
`Taxotere is distributed by Aventis Pharmaceuticals Inc. of Bridgewater, NJ.
`#
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`AVENTIS EXHIBIT 2058
`Mylan v. Aventis, IPR2016-00712
`
`
`
`9/10/2015
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`2004 > FDA Approves New Indication for Taxotere -- Prostate Cancer
`
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