Aug 17 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for its bladder cancer therapy Valstar, which was withdrawn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)