FDAnews Drug Daily Bulletin

FDA Advisers Urge Approval of Cangene’s Botulism-Fighting Biologic

Feb. 14, 2013
A A
Citing scarce treatment options for botulism, the FDA’s Blood Products Advisory Committee has recommended approval of Cangene’s botulinum antitoxin derived from equine sources. Efficacy studies of the Canadian company’s Botulism Antitoxin Heptavalent (H-BAT) in animals showed the product is reasonably likely to provide clinical benefit for humans, the committee said in a unanimous vote.
Drug Industry Daily