Indevus gets approvable letter for bladder cancer therapy
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IDEV.O said it received an "approvable letter" from U.S. regulators for its bladder cancer therapy Valstar, which was withdrawn from the market in 2002 due to impurities in the original formulation.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)
- Google bus blocked in San Francisco gentrification protest
- Thai PM urges protesters to take part in election |
- Obama, Castro shake hands as world says farewell to peacemaker Mandela |
- North Korea's 'reign of terror' worries South's leader
- Rare Singapore riot forces soul searching over foreign workers