Today, the U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.
Category Archives: Food Safety News
FDA approves first cell-based product to treat oral mucogingival conditions in adults
The Food and Drug Administration today approved GINTUIT, the first cell-based product made from allogeneic human cells (from a donor unrelated to the patient) and bovine collagen. GINTUIT is indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.
Gerber Voluntarily Withdraws a Specific Batch of Gerber® Good Start® Infant Formula and Offers Replacement Product to Consumers
Gerber Products Company is proactively retrieving and offering a replacement to consumers who purchased Gerber® Good Start® Gentle powdered infant formula 23.2 ounce plastic package from batch GXP1684 expiration date of March 5, 2013. The product poses no health or safety risk.
Read The Complete Story!
FDA Commissioner Margaret A. Hamburg’s Statement on the Surgeon General’s Report
Tobacco use is the leading cause of preventable death in our nation. And until we dramatically decrease the access and appeal of tobacco products to youth, it will remain one of America’s most pressing health problems. Today’s ground-breaking report by the Surgeon General not only documents the devastating consequences of tobacco use for our nation’s youth, but also represents a clarion call for bold action at every level of government to implement proven strategies to keep kids off tobacco.
FDA approves Surfaxin to prevent breathing disorder in premature infants
The U.S. Food and Drug Administration today approved Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants.
FDA issues warning letter to makers of AeroShot “caffeine inhaler”
The U.S. Food and Drug Administration today issued a warning letter to Breathable Foods Inc., makers of AeroShot, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the use of AeroShot by children and adolescents and in combination with alcohol.
Western Feed, LLC Conducts Voluntary Recall Of Feed Distributed In Nebraska And Wyoming
Western Feed, LLC is voluntarily recalling two lots (M718430 and M720280) of Kountry Buffet 14% feed because it may contain monensin sodium (Rumensin). The feed is packaged in 50 lb. bags bearing the Payback logo with the attached tag identifying the product as Kountry Buffet 14%.
Read The Complete Story!
FDA approves two new pancreatic enzyme products to aid food digestion
Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved today by the U.S. Food and Drug Administration.
FDA approves first quadrivalent vaccine to prevent seasonal influenza
FluMist Quadrivalent, a vaccine to prevent seasonal influenza in people ages 2 years through 49 years, has been approved today by the U.S. Food and Drug Administration. FluMist Quadrivalent is the first influenza vaccine to contain four strains of the influenza virus, two influenza A strains and two influenza B strains.
FDA announces safety changes in labeling for some cholesterol-lowering drugs
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration (FDA).
These products, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).