Kiehuy058 2010-4-29 10:57
FDA核准新的胰臟酵素產品
作者：Jim Kling
出處：WebMD醫學新聞
April 13, 2010 — 美國食品藥物管理局(FDA)核准第三個胰臟酵素產品(商品名Pancreaze延長釋放膠囊，Johnson Johnson公司)，用於治療囊狀纖維化、慢性胰臟炎、胰臟腫瘤、胰臟切除和其他狀況引起的胰臟外分泌不足(exocrine pancreatic insufficiency)。
這個產品將可增加胰臟酵素產品之供應給200,000名以上的美國病患，這些病患以前只能仰賴FDA核准的Creon (Abbott Products公司)以及Zenpep (Eurand Pharmaceuticals藥廠)，還有未經核准的、流通多年的版本，不過，在2010年4月28日之後將不再可得。
藉由此次核准，預期供應將可符合需求，而可改善病患特定治療選項的可近性。
FDA胃腸道產品小組主任Donna Griebel醫師在該局的新聞稿中表示，核准Pancreaze，加上原有的Creon和Zenpep，讓病患與健康照護專業人士可以選擇適用的胰臟酵素產品。
FDA Approves New Pancreatic Enzyme Product
By Jim Kling
Medscape Medical News
April 13, 2010 — The US Food and Drug Administration (FDA) has approved a third pancreatic enzyme product (Pancreaze delayed-release capsules, Johnson Johnson) for the treatment of exocrine pancreatic insufficiency resulting from cystic fibrosis, chronic pancreatitis, pancreatic tumors, pancreatectomy, and other conditions.
The product is intended to increase the supply of pancreatic enzyme products for 200,000 or more US patients who formerly relied only on FDA-approved Creon (Abbott Products, Inc) and Zenpep (Eurand Pharmaceuticals), as well as unapproved versions that have been circulating for many years but will be unavailable after April 28, 2010.
With this approval, supplies are expected to meet demand and also improve accessibility to patient-specific treatment options.
"The approval of Pancreaze, along with Creon and Zenpep, allows patients and healthcare professionals to choose the approved pancreatic enzyme product that is appropriate for them," said Donna Griebel, MD, director of the FDA's Division of Gastroenterology Products, in an agency news release.