FDA News & Alerts
Rituxan Approved to Treat Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) has approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer. Rituxan, an anti-cancer drug, is intended for patients with CLL who are beginning chemotherapy for the first time and for those who have not responded to other... »
Onglyza, a New Type 2 Diabetes Drug Approved by FDA
The U.S. Food and Drug Administration (FDA) today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels. The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have... »
Colchicine for Acute Gout, Familial Mediterranean Fever Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved Mutual Pharmaceutical Company's drug, Colcrys, to treat acute flairs in patients with gout, a recurrent and painful form of arthritis, and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder. The medication’s active ingredient is colchicine, a complex compound derived from the dried seeds... »
FDA Approves Caldolor – Injectable Form of Ibuprofen
The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever. »
Samsca Approved by FDA to Treat Hyponatremia
The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood. “With the approval of Samsca, physicians will have an additional tool to treat hyponatremia,” said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for... »
FDA Approves Use of Temporary Pump to Assist Heart’s Right Side
The U.S. Food and Drug Administration(FDA) today approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of the heart. The approval is a first for certain critically ill patients. »
Experimental Malaria Vaccines to be Tested in FDA and PATH-MVI Collaboration
The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. »
FDA Calls for Warning on Cipro, Levaquin and Other Antibiotics
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin),... »
FDA Warns of Cancer Risk for Regranex in Treatment of Diabetics’ Foot and Leg Ulcers
The U.S. Food and Drug Administration (FDA) has announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and... »
FDA Approves NovoSeven RT Coagulation Therapy
A new formulation of a genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood—has been approved by the FDA. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years. »