Trusted Pharmacy Blog|New Drugs, Drug News, Health, Medications, Diseases

The FDA has approved a once-daily tablet combining amlodipine (Norvasc), a calcium-channel blocker, and olmesartan medoxomil (Benicar drags), an angiotensin-receptor blocker, for the treatment of hypertension. In clinical trials, Azor produced significant mean reductions in systolic and diastolic blood pressure. When compared with generic amlodipine 10 mg alone, Azor 10/40 mg resulted in a 53% greater reduction in systolic blood pressure.

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Lanreotide acetate (Somatuline Depot Injection, Tercica) has been approved for the treatment of acromegaly, a rare and potentially life-threatening disease in adults. Abnormal secretion of growth hormone (GH) is commonly caused by a benign tumor in the pituitary gland.

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Evithrom (Omrix), a blood-clotting protein used to help control bleeding during surgery, is the first human thrombin approved since 1954.

Evithrom is indicated when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue. It may also be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels.

In a clinical trial, it was comparable to cattle-derived thrombin in both safety and effectiveness.

(Source: FDA, August 28, 2007.)

A new vaccine has been licensed to protect people against smallpox. ACAM 2000 (Acambis) is indicated for the inoculation of those at high risk of exposure to smallpox, and it can be used in the event of a bioterrorist attack. It will be included in the Centers for Disease Control and Prevention’s (CDC’s) strategic national stockpile of medical supplies. The CDC considers the vaccine a Category A agent, with smallpox representing one of the greatest potential threats for harming public health.

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The U.S. Food and Drug Administration (FDA) has approved the first generic versions of GlaxoSmithKline’s carvedilol drug (Coreg). This drug is approved to treat high blood pressure, mild to severe chronic heart failure, and left ventricular dysfunction following a heart attack.

Multiple generic drug companies manufacture carvedilol tablets in four strengths: 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg. Applications were approved for Actavis Elizabeth LLC, Apotex, Auro-bindo, Caraco, Dr. Reddy’s, Glenmark, Lupin, Mylan, Ranbaxy, Sandoz, Taro, Teva, Watson, and Zydus.

The labeling of the generic products may differ from that of (buy) carvedilol because parts of the agent’s labeling are protected by patents and/or exclusivity.

(Source: FDA, September 5, 2007

Amylin Pharmaceuticals, Inc., has announced the approval of the Symlin Pen 120 and the Symlin Pen 60 devices for administering pramlintide acetate (Symlin) injection. The prefilled pen injectors feature simple, fixed dosing to improve mealtime glucose control. For diabetic patients who use mealtime insulin, the addition of Symlin is thought to enhance glucose control with the potential for weight loss.

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The number of young children taking prescription drugs for heartburn and other digestive problems has increased by more than 50% in recent years. A report by Medco Health Solutions suggests that more than two million children 18 years of age and younger used drugs for digestive or gastrointestinal complaints in 2006.

Acid-reducing drugs, or proton pump inhibitors (PPIs), are the most common medications prescribed for acid reflux associated with heartburn and gastroesophageal reflux disease. Heartburn is a common complication of being overweight. More than 10% of preschoolers and 30% of older children are considered overweight.

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