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FDA Clears Semisynthetic Taxol

FDA Clears Semisynthetic Taxol

ROCKVILLE, Md--The Food and Drug Administration has approved a semisynthetic source of Bristol-Myers Squibb Company's anticancer agent Taxol (paclitaxel), produced from renewable Taxus baccata plant sources.

Previously, the only source of pac-litaxel approved for human use was the bark of the Pacific yew, an endangered tree found in the Northwest region of the United States. The use of renewable sources completely eliminates the need for Pacific yew bark harvesting and ensures the continuous availability of the agent for patients with metastatic ovarian or breast cancer.

In clearing semisynthetic paclitaxel, the FDA determined that it is bioequivalent to that produced from yew bark. The production process involves extraction of a precursor to paclitaxel from Taxus baccata sources, such as needles and twigs, which is then synthesized to the active ingredient, paclitaxel, and formulated into finished Taxol.

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