Britain’s GlaxoSmithKline pulls application to sell enlarged prostate drug for blocking cancer
By APMonday, November 23, 2009
GlaxoSmithKline pulls application for new drug use
TRENTON, N.J. — British drugmaker GlaxoSmithKline PLC says it’s withdrawing its application for U.S. approval of a drug to prevent prostate cancer.
The drug is already sold under the name Avodart, for treating symptoms of an enlarged prostate.
The company was seeking approval for a new use, reducing risk of prostate cancer, after research showing Avodart could reduce that risk by 25 percent.
GlaxoSmithKline says it wants to provide an update to its application to the Food and Drug Administration. Those applications generally include thousands of pages of data on testing results and characteristics of an experimental drug.
The company says that its decision is not due to any new findings related to safety or effectiveness of Avodart.
