FDA approves new treatment for late-stage breast cancer
The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
Archive for the ‘Drug Safety Information Podcasts’ category
FDA enters into consent decree with Chicago sprout producer due to unsanitary conditions
U Joo Foods, a Chicago sprout grower and processor and the company’s owner and president, Kiyoung Chin have agreed to enter into a consent decree of permanent injunction sought by the Justice Department on behalf of the U.S. Food and Drug Administration.
FDA seeks input on minimizing disruptions to medical device supply chain during extreme weather events
Today the U.S. Food and Drug Administration is seeking input from industry and the public on the effects of extreme weather and natural disasters on the production and supply of medical devices. The FDA will use the information to identify steps that the agency, manufacturers, and the public can take to prepare for such events.
FDA approves new silicone breast implant
The U.S. Food and Drug Administration today approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan, Inc.
FDA approves first retinal implant for adults with rare genetic eye disease
The U.S. Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted retinal prosthesis (artificial retina), replaces the […]
U.S. Marshals seize drug products distributed by a Florida company
U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration, today seized tainted dietary supplements from Globe All Wellness, LLC (Globe All), in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient.
FDA Commissioner Margaret A. Hamburg’s Statement on the Institute of Medicine’s Report “Countering the Problem of Falsified and Substandard Drugs”
The U.S. Food and Drug Administration commends the Institute of Medicine (IOM) for its thorough discussion and recommendations outlined in its report, “Countering the Problem of Falsified and Substandard Drugs.” The report identifies causes and public health consequences of substandard and falsified drugs and recommends a range of strategies to address the problem and to […]
Court shuts down U.S. operations of California drug, dietary supplement manufacturer
A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act (the Act).
FDA approves Pomalyst for advanced multiple myeloma
The U.S. Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
FDA offers new guidance on developing drugs for Alzheimer’s disease
Alzheimer’s disease draft guidance
The Nutrition Facts Label: Helping Americans Make Heart-Healthy Choices
February is American Heart Month, and the U.S. Food and Drug Administration has a tool to help you achieve a heart-healthy lifestyle. It’s called the Nutrition Facts Label, and it can be found on all packaged foods and beverages.
FDA approval of generic version of cancer drug Doxil is expected to help resolve shortage
generic Doxil, doxorubicin, Sun Pharmaceuticals
Michigan soy processor is under court order to meet FDA food safety standards
Green Hope LLC, which does business as Rosewood Products, and owner, Phi G. Ye, of Ann Arbor, Mich., have agreed to a consent decree of permanent injunction for violations of FDA food safety regulations. The consent decree was signed by Judge David M. Lawson of the U.S. District Court for the Eastern District of Michigan, […]
FDA approves new drug for the chronic management of some urea cycle disorders
The U.S. Food and Drug Administration today approved Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients ages 2 years and older.
Federal judge approves consent decree with Ben Venue Laboratories
The U.S. Food and Drug Administration announced today that a federal judge has approved a consent decree of permanent injunction against Ben Venue Laboratories, Inc., and three of its corporate officers for failing to comply with current good manufacturing practice requirements as required by federal law.
FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder
The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).
FDA: Puerto Rico beverage manufacturer enters into consent decree
The U.S. Food and Drug Administration announced today that Jonlly Fruits, Inc. (Jonlly), and its President, Bartolo Pérez Román (Defendants), have signed a consent decree of permanent injunction prohibiting distribution of their fruit and juice products sold under Jonlly’s own label, as well as “Natural Tropic,” “Selectos,” and several other private-label brands.
FDA approves Gleevec for children with acute lymphoblastic leukemia
The U.S. Food and Drug Administration today approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
FDA approves three new drug treatments for type 2 diabetes
The U.S. Food and Drug Administration today approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets.