Drug Approvals
Xifaxan Approved by FDA for Patients with Liver Disease
The U.S. Food and Drug Administration (FDA) today approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease. This is a new use for Xifaxan (rifaximin), a drug that has been approved for the treatment of traveler’s diarrhea. Hepatic encephalopathy... »
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 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. »
New Crohn’s Disease Treatment Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved a new medicine called Cimzia for the treatment of Chron's disease. The drug is manufactured by UCB, Inc., and is known as a tumor necrosis factor (TNF) blocker. It is used to reduce the signs and symptoms of moderately to severely active Crohn's disease... »
FDA Approves Amitiza to Treat Irritable Bowel Syndrome (IBS-C)
The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the... »
Generic Fosamax Approved for Osteoporosis Treatment
The U.S. Food and Drug Administration today approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition that causes thinning and weakening of a person's bones. »