迈兰安非他酮缓释片sNDA获FDA批准

Anne

2013年8月23日讯 8月22日宣布，包含盐酸安非他酮缓释片（Bupropion HCl ER Tablets，300mg）生物等效性研究数据的补充简化新药申请（sNDA）获FDA批准，该药是葛兰素史克（GSK）安非他酮缓释片（WELLBUTRIN XL）的仿制药，用于重度抑郁症（MDD）的治疗。Mylan于2010年9月向美国市场推出盐酸安非他酮缓释片（150mg和300mg）。
在2012年12月发布的信函中，FDA要求所有销售盐酸安非他酮缓释片（300mg）的仿制药公司开展一项空腹生物等效性研究，将其所销售的药品与GSK的品牌药（300mg）进行比较。
2013年4月，迈兰向FDA提交了sNDA，包含了FDA所要求的比对试验数据，证明了迈兰所销售的盐酸安非他酮缓释片（300mg）与GSK安非他酮缓释片（300mg）的生物等效性英文原文：Mylan Confirms Approval of sANDA for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg
PITTSBURGH, Aug. 22, 2013 /PRNewswire/ -- Mylan Inc. today confirmed that the company has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) providing bioequivalence study results requested by FDA for Bupropion Hydrochloride (HCl) Extended-release (ER) Tablets USP (XL), 300 mg. Bupropion HCl ER Tablets USP (XL) are the generic version of WELLBUTRIN XL((R)) and are indicated for the treatment of major depressive disorder (MDD).(1) Mylan launched its Bupropion HCl ER Tablets USP (XL), 150 mg and 300 mg, to the U.S. market in September 2010.
In a correspondence issued December 2012, FDA requested all generic drug companies marketing a version of Bupropion HCl ER Tablets, 300 mg, to conduct a fasting bioequivalence (BE) study comparing their Bupropion HCl ER tablets, 300 mg, to GSK's WELLBUTRIN XL (Bupropion Hydrochloride Extended-release) Tablets, 300 mg. In April 2013, Mylan submitted to FDA a sANDA containing the requested study, which demonstrated bioequivalence of Mylan's Bupropion HCl ER Tablets USP (XL), 300 mg, to WELLBUTRIN XL(R) Tablets, 300 mg.
For the 12 months ending June 30, 2013, Bupropion Hydrochloride Extended-release Tablets, 150 mg and 300 mg, had U.S. sales of approximately $503.3 million, according to IMS Health.
Currently, Mylan has 179 ANDAs pending FDA approval representing $84 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $23.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS Health.

黄四郎

感谢anna姐对前沿动态的追踪，能否附上原文链接呢？{:soso_e177:}