PharmaEngine's pancreatic cancer treatment is approved by TFDA
March 14, 2016 Source: BioSpectrum
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Taiwanese company PharmaEngine recently received an approval from the Taiwan Food and Drug Administration ( TFDA ) for its product ONIVYDE (Irinotecan liposome injection, kidney IRI ). ONIVYDE treats metastatic adenocarcinoma patients with post-treatment of gemcitabine-based pancreatic cancer by combining with fluorouracil ( 5-FU ) and calcium leucovorin ( LV ).
Taiwan’s approval of new drugs is a two-step process. The first step is to assess whether the data on quality, safety, and efficacy of the chemical, manufacturing, and control, incubation, and clinical phases is sufficient for future approvals. The second step is to assess whether the product label and instructions are Can be supported by its new drug application materials. Two steps are indispensable.
PharmaEngine of C. Grace Yeh said that he was grateful TFDA so fast and efficient through the approval and support of their authorized partners Merrimack Pharmaceuticals thanked, the good news opened a new era PharmaEngine toward commercial pharmaceutical companies transition from research and development company .
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