The U.S. Food and Drug Administration today announced that U.S. District Judge Carlos E. Mendoza entered an order of permanent injunction against Paul W. Franck of Ocala, Florida. According to the complaint filed with the consent decree, Franck manufactured and distributed drug products that were adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The U.S. Department of Justice brought the action on behalf of the FDA.

The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.

The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses

The U.S. Food and Drug Administration today announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.

The U.S. Food and Drug Administration announced today it is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco use – including nicotine addiction, gum disease, tooth loss, and multiple kinds of cancer – are being highlighted through the placement of advertisements in 35 U.S. markets specifically selected to reach the campaign’s target audience.

The U.S. Food and Drug Administration today approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains.