The U.S. Food and Drug Administration today allowed marketing of the Verify Cronos Self Contained Biological Indicator (SCBI), a new test that can help speed the determination of whether steam sterilization of reusable medical devices is effective.
The U.S. Food and Drug Administration has announced that the United States District Court for the District of Vermont entered a consent decree of permanent injunction against Lawson Farm of Irasburg, Vermont, its owner, Robert Lawson, and its manager, George R. Lawson, for selling cows and bull calves for human food that contain illegal drug […]
The U.S. Food and Drug Administration will detain shipments of pomegranate seeds from Goknur Gida Maddeleri Ithalat Ihracat Tic (Goknur Foodstuffs Import Export Trading) of Turkey when they are offered for import into the United States.
The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.
A federal judge from the U.S. District Court for New Jersey has entered a consent decree of permanent injunction against Med Prep Consulting, Inc., a pharmacy licensed by the state of New Jersey, and Gerald R. Tighe, the company’s president and owner. The U.S. Department of Justice sought the consent decree on behalf of the […]
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.
The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes, perioperative (period extending from the time of hospitalization for surgery to the time of discharge) management, […]
For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the U.S. Food and Drug Administration the authority to regulate tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence (SE) pathway.
Today, the U.S. Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 order of the United States District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter […]
Acting Assistant Attorney General Stuart F. Delery announced today that the Department of Justice, on behalf of the Food and Drug Administration (FDA), has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals, Inc. (Sage), its president Dr. Jivn-Ren Chen, and its Director of Corporate Quality, Charles L. […]
The U.S. Food and Drug Administration announced today that the U.S. is now a “listed” country with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.
The U.S. Food and Drug Administration today expanded the approved use of the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Vibativ should be used for the treatment of HABP/VABP only when alternative treatments are not suitable.
The U.S. Food and Drug Administration today approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying. The Abbott RealTime HCV Genotype II, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5, using a sample of an infected patient’s blood plasma or serum, will aid […]
The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC.
The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
iTrace for Blood Centers, (Version 1.0.924.0), the first application to use Radio Frequency Identification (RFID) technology in blood establishments to assist in enhancing blood safety by preventing the release of unsuitable blood components, was cleared today by the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.