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عضو محترف - مشرف القسم السعودي
التسجيل
24 مايو 2004
المشاركات
3,425
لم يتم الموافقه من fda علي الدواء

DOR BioPharma Receives Not Approvable Letter From FDA for orBec(R) for Treatment of Gastrointestinal Graft-vs.-Host Disease

Internet Wire via COMTEX


Oct 19, 2007 8:51:42 AM

DOR Committed to Addressing Unmet Medical Needs of GVHD Patients

EWING, NJ, Oct 19, 2007 (MARKET WIRE via COMTEX News Network) --

DOR BioPharma, Inc. (OTCBB: DORB) ("DOR," or "Company") announced today that it has received a not approvable letter from the US Food and Drug Administration (FDA) for its lead product orBec(R) (oral beclomethasone dipropionate, or oral BDP) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation

The FDA has requested data from additional clinical trials to demonstrate the safety and efficacy of orBec(R). Additionally, the FDA has requested information with respect to other sections of the NDA.​

مطالبين بمعلومات زياده عن فعاليه الدواء ميدانيا

سلالالالالالالالالالالام
 

الجاسوسة

موقوف
التسجيل
15 أكتوبر 2007
المشاركات
134
لم يتم الموافقه من fda علي الدواء

DOR BioPharma Receives Not Approvable Letter From FDA for orBec(R) for Treatment of Gastrointestinal Graft-vs.-Host Disease

Internet Wire via COMTEX


Oct 19, 2007 8:51:42 AM

DOR Committed to Addressing Unmet Medical Needs of GVHD Patients

EWING, NJ, Oct 19, 2007 (MARKET WIRE via COMTEX News Network) --

DOR BioPharma, Inc. (OTCBB: DORB) ("DOR," or "Company") announced today that it has received a not approvable letter from the US Food and Drug Administration (FDA) for its lead product orBec(R) (oral beclomethasone dipropionate, or oral BDP) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation

The FDA has requested data from additional clinical trials to demonstrate the safety and efficacy of orBec(R). Additionally, the FDA has requested information with respect to other sections of the NDA.​

مطالبين بمعلومات زياده عن فعاليه الدواء ميدانيا

سلالالالالالالالالالالام

يعني السهم أخوي بوياسر ينفع بونسينج و لا ما تنصح
 
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