The FDA has slapped Canada-based Biovail with a Non-Approval letter for BVF-033, a once-daily salt formulation of bupropion. The FDA said the design of the pharmacokinetic studies required to support the NDA was not sufficient. The company said that though it believes the studies were adequate, it will meet with the agency to resolve the problem.
- see the release [1] for more
PLUS: Funding remains crucial for Canada's biotech industry. Release [2]
Related Articles:
Biovail's Melnyk to step down amid SEC probe [3]
Biovail chairman charged with securities violations [4]
Biovail loses effort to stop generic Wellbutrin [5]
Biovail to spin off older drugs, start new pharma co. [6]
Links:
[1] http://www.fiercebiotech.com/node/7724
[2] http://www.fiercebiotech.com/node/7719
[3] http://www.fiercebiotech.com/story/chutes-ladders-biovail-s-melnyk-to-step-down-amid-sec-probe/2007-05-16
[4] http://www.fiercebiotech.com/story/biovail-chairman-charged-with-securities-violations/2006-08-01
[5] http://www.fiercebiotech.com/story/biovail-loses-effort-to-stop-generic-wellbutrin/2006-09-14
[6] http://www.fiercebiotech.com/story/biovail-to-spin-off-older-drugs-start-new-pharma-co/2005-11-16