FDA Requires More Data on Watson Prostate Cancer Drug, Trelstar

The Food and Drug Administration is asking Watson Pharmaceuticals, Inc. to do more work on the company’s new, long-term dose version of its prostate cancer drug, Trelstar, before the agency grants an approval.

Watson had asked the FDA to approve a new, longer-action formulation of Trelstar, which is currently available in four-week and 12-week doses. The injectable drug suppresses the production of testosterone and is used to treat prostate cancer patients whose condition has advanced, who are not candidates for surgery to remove the testicles, and for whom estrogen therapy is not feasible, according to a Reuters news report.

The FDA sent Watson what is called a complete response letter requesting more information about clinical testing, chemistry, and other aspects of the 24-week formulation of Trelstar. The FDA also wants more information about the third-party manufacturing agreement Watson says it will use to produce the new formulation of Trelstar if it is approved.

The proposed 22.5-milligram formulation of the drug steadily suppresses testosterone production for 24 weeks and lasts twice as long as the company’s current long-acting dosage.

Watson officials said they were working “expeditiously” to provide the FDA with the requested information in hopes of earning approvals for the new, longer-formulation version of Trelstar.

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