FDA批准首先吡格列酮片仿制药

8月17日，美国食品和药物管理局批准了艾可拓(Actos,吡格列酮片)的第一个仿制药。配合节食和锻炼，吡格列酮可以改善2型糖尿病成人患者的血糖控制。

位于西弗吉尼亚州摩根城的迈兰(Mylan)制药公司的15毫、30毫克和45毫克吡格列酮片获得了FDA批准。

“控制血糖值对防止或减少糖尿病的长期并发症是非常重要的” FDA药物评价和研究中心仿制药办公室主任、医学博士、公共卫生硕士格列高利·迦巴说， “广泛应用的吡格列酮的仿制药为必须应对此种慢性、潜在严重病症的患者提供了负担得起的治疗方案的选择。”

糖尿病是一种血糖浓度过高的疾病。葡萄糖大部分来自于我们吃的食物。胰岛素是一种可以将葡萄糖动送至人体细胞，以帮助他们产生能量的激素。2型糖尿病人体内不能充分产生或使用胰岛素。如果没有足够的胰岛素，葡萄糖将留在血液中。随着时间的推移，血液中的葡萄糖太多可能会导致严重的健康问题，如眼睛、肾脏和神经损伤。糖尿病也会增大心脏疾病和中风的风险。

药物治疗指南为服用吡格列酮的患者提供了该药使用和药物安全的重要信息。该药物带有一个黑框警告以强调吡格列酮可能引起或加重心脏衰竭，特别是在某些患者人群。建议在患者开始服药或增加剂量时应仔细监测其血糖水平。在产品标签上也注明了使用吡格列酮超过一年可能与患膀胱癌风险增加有关。

吡格列酮患者使用报告的最常见不良反应包括：感冒样症状、头痛、鼻窦感染、肌肉痛和喉咙痛。吡格列酮仿制药相关信息可从制造商处获得。

FDA批准的仿制药与品牌药具有相同的高品质和疗效。通用仿制药的生产和包装场所必须经过与品牌药品相同的质量标准检验。

For Immediate Release: Aug. 17, 2012
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves first generic Actos to treat type 2 diabetes

The U.S. Food and Drug Administration today approved the first generic version of Actos (pioglitazone hydrochloride) tablets. Along with diet and exercise, pioglitazone is used to improve blood glucose control in adults with type 2 diabetes.

Mylan Pharmaceuticals, based in Morgantown, W.Va., gained FDA approval for 15 milligram, 30 mg and 45 mg pioglitazone tablets.

“Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,” said Gregory P. Geba, M.D., M.P.H., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.”

Diabetes is a disease in which blood glucose, or sugar, levels are too high. Glucose comes largely from the food we eat. Insulin is a hormone that helps move glucose into the body’s cells to help them produce energy. In people with type 2 diabetes the body does not make or use insulin well. Without enough insulin, glucose stays in the blood. Over time, too much glucose in the blood can cause serious health problems such as damage to eyes, kidneys, and nerves. Diabetes can also contribute to heart disease, and stroke.

Pioglitazone is dispensed with a patient Medication Guide that provides important instructions about its use and drug safety information. The drug has a Boxed Warning to emphasize that pioglitazone may cause or worsen heart failure, particularly in certain patient populations. Careful monitoring of patients when starting the drug or increasing the dose is recommended. The product label also notes that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.

The most common side effects reported by patients using pioglitazone include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat. Information about the availability of generic pioglitazone can be obtained from the manufacturer.

Generic drugs approved by FDA are of the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs.