The Food and Drug Administration Friday approved the first drug intended to treat smallpox, which was eradicated in 1980 but could be used as a bioweapon. “This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” said FDA Commissioner Scott Gottlieb, M.D. Developed in conjunction with the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, the drug was approved under the FDA’s Animal Rule, which allows efficacy findings from animal studies to support approval when it is not feasible or ethical to conduct efficacy trials in humans. Its safety was evaluated in 359 healthy human volunteers without a smallpox infection. In other news, FDA announced a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure, due to an impurity that could cause cancer. Patients taking the recalled products should contact their pharmacist or doctor to discuss treatment options, which may include a valsartan product not affected by the recall, the agency said.

Related News Articles

Headline
The AHA, American Medical Association, American Society of Anesthesiologists, American Society of Health-System Pharmacists, and Association for Clinical…
Headline
Reps. Scott Peters, D-Calif., Eliot Engel, D-N.Y., Brett Guthrie, R-KY, Anna Eshoo, D-Calif., Richard Hudson, R-N.C., Michael McCaul, R-Texas, Kurt Schrader, D…
Headline
The Food and Drug Administration today released a proposed rule that would allow states and other non-federal government entities to establish programs to…
Headline
The Food and Drug Administration yesterday approved the first test to use next generation sequencing technology to detect HIV drug-resistance mutations in…
Headline
Pictured, from left to right: Peter Adamson, chair of the Children’s Oncology Group at the Children’s Hospital of Philadelphia; Brian Marden, chief…
Headline
The AHA, American Society of Anesthesiologists, American Society of Clinical Oncology, American Society of Health-System Pharmacists and Institute for Safe…