FDA warns consumers not to use muscle growth product
The U.S. Food and Drug Administration is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to...
View ArticleFDA approves Tretten to treat rare genetic clotting disorder
The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and...
View ArticleFDA announces voluntary nationwide recall of all non-expired sterile drugs...
The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by...
View ArticleFDA proposes new food defense rule
As required by the bipartisan Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration today proposed a rule that would require the largest food businesses in the United States and...
View ArticleMontana dietary supplement maker found in contempt of court
The U.S. Food and Drug Administration announced today that on Dec. 4, 2013, a Livingston, Mont., dietary supplement maker was found in civil contempt of court for repeatedly violating the terms of a...
View ArticleFDA allows marketing of new stent for treating pseudocysts of the pancreas
The U.S. Food and Drug Administration today allowed marketing of the AXIOS Stent and Delivery System for treating pseudocysts (fluid and tissue filled cavities) that form in the pancreas and are next...
View ArticleFDA approves Anoro Ellipta to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients...
View ArticleFDA and European Medicines Agency launch generic drug application inspections...
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in...
View ArticleFDA issues proposed rule to determine safety and effectiveness of...
The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily...
View ArticleFDA allows marketing of first device to relieve migraine headache pain
The U.S. Food and Drug Administration today allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an...
View ArticleUSPlabs LLC recalls OxyElite Pro dietary supplements; products linked to...
The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this...
View ArticleFDA approves Aptiom to treat seizures in adults
The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
View ArticleFDA approves first generic versions of Aciphex delayed-release tablets to...
The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults...
View ArticleFDA takes action to speed safety information updates on generic drugs
A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use...
View ArticleFDA takes step to further reduce trans fats in processed foods
The U.S. Food and Drug Administration announced its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not...
View ArticleFDA: Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion...
On behalf of the U.S. Food and Drug Administration, the U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400...
View ArticleFDA approves Gazyva for chronic lymphocytic leukemia
The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
View ArticleFDA takes two important actions on drug shortages
The U.S. Food and Drug Administration is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and...
View ArticleFDA approves extended-release, single-entity hydrocodone product
The U.S. Food and Drug Administration today approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term...
View ArticleFDA approves second brain imaging drug to help evaluate patients for...
The U.S. Food and Drug Administration today approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults...
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