What You Need to Know About Caralluma Fimbriata
Caralluma fimbriata is a succulent plant, in the cactus family, that has been used as a natural appetite suppressant in India for centuries. It’s a new arrival in the family of cactii and succulent plants that are becoming increasingly popular for th…
FDA Prevents Two Dairies from Adulterating Animal Drugs and Food
The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M.
FDA Announces Class I Recall of Ophthalmic Surgical Device
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.
FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue
The U.S. Food and Drug Administration today approved the cobas TaqScreen MPX Test, the first nucleic acid test that screens for the presence of two divergent types of HIV in donated blood plasma and tissue.
FDA Approves Drug for Patients with Advanced Prostate Cancer
The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.
FDA Approves First Imaging Agent to Enhance Scans of Blood Flow
The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels.
FDA Warns Consumers About Tainted Weight Loss Pills
The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.
FDA Obtains Injunction to Stop Production of Illegally Medicated Animal Feed
The U.S. Food and Drug Administration announced today that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe, Mo., from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds.
FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes
The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.
FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications
The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products’ prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality).
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