Tentative FDA Approval for Generic Version of Taxol
(MIAMI, FL)Ivax, Corporation has received tentative approval from the Food and Drug Administration (FDA) for paclitaxel, a generic form of the cancer drug Taxol, made by Bristol-Myers Squibb Company. However, due to a pending lawsuit and patent litigation against Bristol-Myers, it may be as long as 30 months until Ivax can begin selling the new drug. If Ivax obtains final clearance to sell the generic form of Taxol, it is entitled to 180 days of marketing exclusivity for having been the first to file with the FDA. For more information, visit www.fda.org.
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