FDA News & Alerts
Generic Versions of Cozaar and Hyzaar Tablets Approved for Hypertension Treatment
The U.S. Food and Drug Administration approved today the first generic versions of two drugs used for the treatment of hypertension. Losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets (a combination drug) are the generic equivalents of Cozaar and Hyzaar tablets, respectively. Cozaar and Hyzaar tablets are widely-used antihypertensive drugs. Both generic losartan... »
New OxyContin Formulation Designed to Discourage Abuse of the Drug
The U.S. Food and Drug Administration today approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication. OxyContin is made to slowly release the potent opioid oxycodone to treat patients who require a continuous, around-the-clock opioid analgesic for management of their moderate... »
Asclera Approved by FDA for Varicose Vein Treatment
The U.S. Food and Drug Administration today approved Asclera (polidocanol) injection for the treatment of small types of abnormally swollen or twisted veins called varicose veins. Although they usually occur in the legs, varicose veins also can form in other parts of the body. Factors such as genetics, age, female gender, pregnancy, obesity, and... »
FDA Reports Outbreak Related to Raw Milk
Latest outbreak of campylobacteriosis in Midwest is linked to unpasteurized product. The U.S. Food and Drug Administration, along with several state agencies, is alerting consumers to an outbreak of campylobacteriosis associated with drinking raw milk. At least 12 confirmed illnesses have been recently reported in Michigan. Symptoms of campylobacteriosis include diarrhea, abdominal pain and... »
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... »
Zocor May Increase Muscle Injury Risk
The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg. Although muscle injury (called myopathy) is a known side effect with all statins, today’s warning highlights the greater risk of developing muscle injury, including rhabdomyolysis,... »
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. »