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Dutasteride Granted Preliminary Approval

By John Ertel
November 20, 2001

According to the FDA web site, Dutasteride was given preliminary approval for the treatment of Benign Prostatic Hyperplasia (BPH, commonly known as prostate enlargement) on November 20, 2001. Although details are unclear still about final approval and time to market, it should only now be a matter of months before the drug is available for prescription through doctors.

In other news, Glaxo submitted a European marketing application on October 10th, 2001 to begin marketing the drug in Europe as well. It is unknown when approval will be granted in Europe.

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