Indevus gets approvable letter for bladder cancer therapy

Fri Aug 17, 2007 8:28am EDT

Aug 17 (Reuters) - Indevus Pharmaceuticals Inc. IDEV.O said it received an "approvable letter" from U.S. regulators for its bladder cancer therapy Valstar, which was withdrawn from the market in 2002 due to impurities in the original formulation. The biopharmaceutical company said the U.S. Food and Drug Administration, in its letter, asked for clarification on the manufacturing validation protocols and for additional data on the manufacturing process.

The FDA issues approvable letters when it agrees to a drug's use in principle for a particular condition but requires more information on issues such as dosage, potential side effects or labelling. (Reporting by Tenzin Pema in Bangalore)

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