FDA Alerts
New Treatment for Chronic Back Pain Approved
Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain.
FDA Approves Rx for Plague
The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection.
'Double Chin' Treatment Approved
The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat.
First Generic Abilify Approved
The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole).
New Rx for Heart Failure Approved
The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.
Blue Bell Expands Ice Cream Recall
FOR IMMEDIATE RELEASE — April 7, 2015 — Brenham, TX — Blue Bell Creameries is expanding its recall of products that were produced in the Broken Arrow, Okla., plant to include Banana Pudding Ice Cream pints which tested positive for Listeria monocytogenes, and additional products manufactured on the same line.
FDA Approves Test for Delayed Gastric Emptying
The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.
FDA Approves Rx for Inhalation Anthrax
The U.S. Food and Drug Administration yesterday approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.
New Treatment for Diabetic Retinopathy
The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.
FDA Approves Blood Pump System
The U.S. Food and Drug Administration today approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures.