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NDA 206088 This new drug application provides for the use of Otezla (apremilast) tablets, 10, 20 and 30 mg, for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. ÖжÈÖÁÖØ¶È°ß¿éÐÍÒøÐ¼²¡ NDA 205437 This new drug application provides for the use of Otezla (apremilast) tablets , for the treatment of adult patients with active psoriatic arthritis (PsA). ÒøÐ¼²¡¹Ø½ÚÑ×£¨PsA£© https://www.accessdata.fda.gov/d ... 088Orig1s000ltr.pdf https://www.accessdata.fda.gov/d ... 437Orig1s000ltr.pdf Á½¸öÊDz»Í¬µÄÊÊÓ¦Ö¢¡£ºÃ±ÈÀñÀ´µÄTaltz£¨Ixekizumab£©£¬2016Äê3ÔÂ22ÈÕÅú×¼µÄÊÊÓ¦Ö¢¾ÍÊÇ the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ËüÏÖÖÂÁ¦¿ª·¢µÄµÚ¶þ¸öÊÊÓ¦Ö¢ÊÇ active psoriatic arthritis (PsA)£¬¾ßÌå½ø¶Èδ¿¼¾¿¡£ÕâÖÖÇé¿ö£¬Ó¦¸ÃÊÇ¿ÉÒÔ¶à¸öNDA£¬Ò²¿ÉÒÔÔÚÔNDA»ù´¡Éϲ¹³äÉêÇë¡££¨Åµ»ªµÄCosentyx¾ÍÊÇÔÚÔNDA»ù´¡ÉÏÔöÖÁ3¸öÊÊÓ¦Ö¢£¬°üÀ¨PsA¡¢As¡¢°ß¿éÐÍ£© |

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