UPDATE 1-FDA denies approval of Watson prostate cancer drug
* FDA seeks clinical testing, manufacturing info
* Watson working to provide requested info
* Shares down 9 cents
NEW YORK, July 14 (Reuters) - Watson Pharmaceuticals Inc
(WPI.N) said U.S. health regulators will require additional
information before approving a new, longer-acting formulation
of its prostate cancer drug Trelstar.
The U.S. Food and Drug Administration, in a so-called complete response letter, requested clarification on clinical testing, chemistry, manufacturing and controls of the 24-week formulation of the testosterone-suppressing medicine. The agency is also seeking further information on Watson's third-party manufacturing of the injectable drug, the company said.
Watson said it was working "expeditiously" to provide the requested information.
Trelstar, which was developed by Swiss-based Debiopharm Group, is already available in four-week and 12-week formulations. The drug is used to treat advanced prostate cancer in patients for whom removal of the testicles or estrogen therapy is not feasible.
The new 22.5 milligram formulation suppresses testosterone production continuously for 24 weeks, lasting twice as long as Watson's current long-acting version of Trelstar.
Watson shares dropped 9 cents to $33.43 in midday trading on the New York Stock Exchange. (Reporting by I-Ching Ng, editing by Matthew Lewis)
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