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The Food and Drug Administration Friday released draft guidance on how drug developers can apply for the agency’s Competitive Generic Therapies designation.
Headline
Members of the pharmaceutical distribution supply chain, including dispensers such as hospitals and pharmacies, can apply through March 11 to participate in a…
Headline
The U.S. District Court for the Western District of Pennsylvania has entered a consent decree prohibiting Ranier’s Rx Laboratory Inc. from manufacturing or…
Headline
The Food and Drug Administration Friday warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain…
Headline
The AHA today submitted to the Food and Drug Administration legislative, regulatory and best practice recommendations to address new and chronic prescription…
Headline
The Food and Drug Administration yesterday released revised draft guidance for facilities that compound human drugs as outsourcing facilities.