from Wiktionary, Creative Commons Attribution/Share-Alike License.
- adjective Not
from Wiktionary, Creative Commons Attribution/Share-Alike License
The Sunnyvale, Calif., pharmaceutical company received a so-called nonapprovable letter from the FDA for Xcytrin injection in patients with nonsmall-cell lung cancer with brain metastases.
"It's nonapprovable without another clinical trial," said Mike Krensavage, an analyst at Raymond James Financial Inc., worried that the finding of a significant increase in fatal bleeding -- 0.4% of prasugrel patients, compared with 0.1% of those on Plavix -- will require more studies.