U.S. District Judge William P. Johnson of the District of New Mexico has signed a consent decree imposing requirements on Sunland Inc., a manufacturer and distributor of peanut products linked to an outbreak of Salmonella Bredeney, to keep potentially harmful products from entering the marketplace, the U.S. Food and Drug Administration said today.
Category Archives: Food Safety News
FDA approves Varizig for reducing chickenpox symptoms
The U.S. Food and Drug Administration approved Varizig, for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals when given within four days after exposure.
FDA approves Gattex to treat short bowel syndrome
The U.S. Food and Drug Administration today approved Gattex (teduglutide) to treat adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition).
FDA expands Tamiflu’s use to treat children younger than 1 year
The U.S. Food and Drug Administration today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days.
Invacare signs consent decree to correct wheelchair manufacturing problems
The Food and Drug Administration announced today that medical device maker and distributor, Invacare Corp., and two of its top executives have signed a consent decree of permanent injunction requiring the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components.
FDA permits marketing of device to seal lung punctures
The U.S. Food and Drug Administration today allowed marketing of the Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by biopsies performed to confirm a diagnosis of suspected lung conditions.
FDA warns against improper advertising, promotion of lasers intended for LASIK corrective eye surgery
The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.
FDA approves raxibacumab to treat inhalational anthrax
The U.S. Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.
FDA approves Iclusig to treat two rare types of leukemia
The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.
FDA approves Signifor, a new orphan drug for Cushing’s disease
The U.S. Food and Drug Administration today approved Signifor (pasireotide diaspartate) injection for the treatment of Cushing’s disease patients who cannot be helped through surgery.