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DEEP & FAR

 

 

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¦Ó¾Ç¦WÃĤ§¥Ó½Ð¤H¡A¨Ì·Ó21 U.S.C. ¡± 355(j)(2)(A)(i) ³W©w¡AµLªkÀò±o¶W¶VFDA¤w®Ö­ã¥Î³~¤§³\¥i¡A¸Óªk³W¨Ã¥¼­n¨DANDA¥²¶·¥]§t¨C¤@¤w®Ö­ã¤§¾AÀ³¯g (generic applicants cannot obtain approval for uses beyond those already approved by the FDA, 21 U.S.C. ¡± 355(j)(2)(A)(i), nothing in the Act requires that an ANDA must encompass every approved indication.)¡C

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°ê·|»{ª¾³æ¤@ÃĪ«¥i¯à¦³¦h­Ó¾AÀ³¯g¡A¥B¨Ã¥¼³W©wANDA¥Ó½Ð¤H¶È¯à´M¨D¤Ö©ó©Ò®Ö­ã¤§©Ò¦³¾AÀ³¯g¡C°ê·|²M·¡¦a³]·Q¡AFDA ¥i¯à®Ö­ã ......¤@¥óANDA¡A¥H´M¨D³æ¤@ÃĪ«¾AÀ³¯g¤§¦æ¾P(§Y¨Ï¨ä¥L¾AÀ³¯g«Y¤wª¾©Î¤w®Ö­ã)¡C......Ãö©ó½Ð¨D¤@¾AÀ³¯g³Q´M¨DÃÄ«~¥Î³~¤§®Ö­ã¦æ¾P¤§¥Î³~±M§Q¡A¥Ó½Ð¤H¶È»Ý®Ú¾Ú²Ä IVÃþÃÒ©ú¡C([1])

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[1]. Warner-Lambert, 316 F.3d at 1360.