Zeneca Submits SNDA For Zoladex
Zeneca Pharmaceuticals has submitted a Supplemental New Drug Application to the US Food and Drug Administration for a depot formulation of Zoladex (goserelin) in the treatment of prostate cancer. The new formulation is designed to deliver therapeutic levels of the drug continuously for 12 weeks.
Zoladex has been available for the treatment of advanced prostate cancer in the USA since 1989. In 1993, US sales of the drug were over L29 million ($46.7 million). A supplemental NDA for the use of Zoladex to treat advanced pre- and peri-menopausal breast cancer was submitted in August this year.
Mike Carter, international marketing director for Zeneca, said that the new formulation should capture a major share of the total $253 million US gonadotrophin-releasing hormone analog market.
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