FDA - What's News: Drugs
What's New at CDER
Updated: 2 weeks 3 hours ago
FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety
The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia (rosiglitazone).
Current Drug Shortages
Current Drug Shortages: Propofol Injection (updated) 2/24/2010, Acyclovir Tablets and Capsules (updated) 2/22/2010, Technetium Tc99m Generators (updated) 2/18/2010, Heparin Sodium Large Volume Premixed Infusion Solutions 2/16/2010, Vecuronium Injection (updated) 2/12/2010, Thyroid (desiccated) tablets 2/12/2010, Mexiletine Capsules (150mg, 200mg, and 250mg) 2/12/2010, Neupro (rotigotine transdermal system)(updated) 2/5/2010, Pentothal (thiopental) Injection (updated) 2/5/2010, Methotrexate injection (updated) 2/5/2010, Thiotepa 15mg injection (updated) 2/5/2010, Mitomycin for injection (updated) 2/5/2010, Erythromycin Ophthalmic Ointment (updated) 1/26/2010
FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms
The U.S. Food and Drug Administration (FDA) is reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase (saquinavir) in combination with Norvir (ritonavir).
Paragraph IV Patent Certifications
Updated list.
Additions/Deletions for Prescription and OTC Drug Product Lists
The list has been updated through August 2009.
Orange Book Current Cumulative Supplement
January 2010 Cumulative Supplement
Information for Healthcare Professionals: Cefepime (marketed as Maxipime)
The purpose of this communication is to share information about the FDA’s continuing safety review about the potential increased mortality in patients treated with cefepime. Cefepime is a cephalosporin antibacterial and is a member of the β–lactam class of antibacterial drugs.
FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)
Due to safety concerns, the U.S. Food and Drug Administration (FDA) is requiring changes to how long-acting inhaled medications called Long-Acting Beta-Agonists (LABAs) are used in the treatment of asthma.
Warning Letters 2010
Letters added
FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products
The U.S. Food and Drug Administration (FDA) has received five reports of serious medication errors involving consumers who used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication, by mistake, when they had intended to use one of the traditional Maalox liquid antacid products.
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
The Orange Book lists drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act.
Warning Letters 2009
Dr. Charles McKay, Hopewell, Eisai and Shire Warning Letters added
