The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

Today, U.S. District Judge Edward J. McManus for the U.S. District Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.

Three dietary supplement companies, under the same ownership and located in Wautoma, Wisconsin, will not be allowed to manufacture or sell dietary supplement products until FDA has determined that the businesses are in compliance with federal manufacturing regulations and other requirements, according to a federal court order signed Aug. 4, 2015.

On August 3, 2015, U.S. Magistrate Judge Carolyn K. Delaney in the U.S. District Court for the Eastern District of California entered a consent decree against Henh Wong Fresh Produce, a tofu and sprout manufacturer and distributor, and its owner, current manager, and former manager after the U.S. Food and Drug Administration documented multiple violations of federal food safety laws and regulations. The U.S. Department of Justice sought the consent decree on behalf of the FDA.

The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.

The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.

The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

The U.S. Food and Drug Administration today approved Odomzo (sonidegib) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.

The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).

The U.S. Food and Drug Administration today proposed including the percent daily value (%DV) for added sugars on the Nutrition Facts label of packaged foods, giving consumers additional information for added sugars similar to information they have seen for decades with respect to nutrients such as sodium and certain fats.