FDA Alerts
FDA and FTC to Remove Homeopathic Products from the Market
The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.
Abbott Receives Approval for Vitamin D Test
Abbott announced it has received clearance from the U.S. Food and Drug Administration for a fully-automated 25-OH Vitamin D assay performed on its widely used ARCHITECT laboratory testing platform.
FDA Approves Insomnia Drug Intermezzo
The U.S. Food and Drug Administration today approved Intermezzo ( zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.
FDA Approves Eylea For Eye Disorder In Older People
The U.S. Food and Drug Administration today approved Eylea ( aflibercept ) to treat patients with wet ( neovascular ) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.
FDA Revokes Approval of Breast Cancer Drug
FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for Avastin ( bevacizumab ) after concluding that the drug has not been shown to be safe and effective for that use.
FDA Approves First Drug to Treat a Rare Bone Marrow Disease
The U.S. Food and Drug Administration today approved Jakafi ( ruxolitinib ), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis .
Frequently Asked Questions about the FDA Drug Approval Process
Q: Why are drugs evaluated by the FDA?
A: Drugs intended for human use are evaluated by FDA’s Center for Drug Evaluation and Research ( CDER ) to ensure that drugs marketed in the United States are safe and effective. Biological products are evaluated by FDA’s Center for Biologics Evaluation and Research.
Q: Does FDA test drugs?
A: No. It is the responsibility of the company seeking approval to market a drug to conduct laboratory and animal tests on the safety and effectiveness of a proposed new drug and then to submit that information to FDA for review by CDER physicians,...
FDA approves Erbitux to treat late-stage head and neck cancer
The U.S. Food and Drug Administration today approved Erbitux ( cetuximab ) for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer.
FDA Approves Exparel For Postsurgical Pain Management
Pacira Pharmaceuticals, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved EXPAREL (TM) ( bupivacaine liposome injectable suspension) 1.3% for administration into the surgical site to produce postsurgical analgesia.
FDA approves Ferriprox
The U.S. Food and Drug Administration today approved Ferriprox ( deferiprone ) to treat patients with iron overload due to blood transfusions in patients with thalassemia , a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.