Biocon 和 Carnegie 获得 FDA 初步批准用于治疗肝脏和肠道疾病的仿制药利福昔明片剂。 Biocon and Carnegie get FDA tentative approval for generic Rifaximin tablets to treat liver and gut conditions.

生物药剂公司与卡内基制药公司合作,得到林业发展局临时批准,在ANDA下使用550毫克的Rifaximin药片。 Biocon Pharma, in partnership with Carnegie Pharmaceuticals LLC, received tentative FDA approval for Rifaximin Tablets, 550 mg, under an ANDA. 批准该药物是为了减少常见的公开肝炎性脑病,并治疗成人腹泻性肠胃炎和腹泻综合症。 The drug is approved to reduce recurrent overt hepatic encephalopathy and treat irritable bowel syndrome with diarrhea in adults. 此项批准标志着Biocon的美国非专利药物的存在向前迈出了一步。 The approval marks a step forward for Biocon’s U.S. generic drug presence. 一旦专利或独家经营问题得到解决,该产品就可销售。 The product can be marketed once patent or exclusivity issues are resolved. Biocon的股份在BSE宣布后稳定在347。 Biocon’s shares held steady at ₹347 on the BSE after the announcement.