FDA should ensure food safety measures in US

Majority of Voters Support New Government Oversight of Food, Pew Commissioned Poll Finds – Most Americans support for measures that would give the Food and Drug Administration (FDA) new authority to ensure the food Americans eat does not make them sick.

FDA declines Fusilev NDA for colorectal cancer

Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for FUSILEV(R) in Advanced Metastatic Colorectal Cancer – A Complete Response letter is issued by the U.S. Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for injection for treatment of patients with advanced metastatic colorectal cancer.

Eurand’s Zenpep pancreatic enzyme product approved by FDA

Eurand Granted FDA Approval for ZENPEP(TM) — First and Only FDA-Approved Pancreatic Enzyme Product Clinically Tested in Patients Under 12 Years Old. – U.S. Food and Drug Administration (FDA) has approved Eurand’s New Drug Application (NDA) for ZENPEP(TM) (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.

Boxed warning required for Chantix and Zyban, says FDA

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban – Smoking cessation drugs Chantix and Zyban are causing unusual changes in behavior, depression, and suicidal thinking in those who have taken these drugs to quit their smoking habits.

Takeda’s diabetes drug alogliptin received FDA’s objection

Takeda receives FDA Complete Response letter for alogliptin, an investigational treatment for type 2 diabetes. – US top most health agency FDA has asked Takeda to conduct an additional clinical trial to rule out any adverse effects of alogliptin in relation to heart, that means Takeda needs to conduct a cardiovascular safety trial for alogliptin.

Improve contact lens safety, says US FDA

FDA Taking Steps to Improve Contact Lens Safety – The U.S. Food and Drug Administration is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures.

FDA reviewing stimulant medications for ADHD

FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD – U.S. Food and Drug Administration (FDA) issues safety communication about an ongoing review of stimulant medications used in children with ADHD (Attention deficit hyperactivity disorder).

FDA warns consumers not to use skin care products by Clarcon

FDA Warns Consumers Not to Use Skin Products Made by Clarcon Due to Bacterial Contamination Risk – Products marketed under various names. – The U.S. Food and Drug Administration announced that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection.

Option Inferior Vena Cava Filter gets FDA clearance in US

Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena Cava Filter – Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Option(TM) Inferior Vena Cava (IVC) Filter in the United States, for use in both permanent and retrievable indications.

FDA forms Transparency Task Force

The U.S. Food and Drug Administration FDA Forms Transparency Task Force – The U.S. Food and Drug Administration (FDA) announced the formation of a task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process.

Health Newstrack