How can applicants reduce the risk that the FDA will issue a
Complete Response letter?
Because the most recent
Complete Response Letter did not contain any specific requirement to conduct any additional clinical work or other specific guidance to address the issue raised by the FDA, Somaxon believes that a meeting with the FDA will be necessary to discuss the basis for the FDA's decision and to seek such specific guidance.
The overall
complete response rate in these patients was 61.
In its
Complete Response letter, the FDA states that it cannot approve the NDA in its current form and specifies additional actions and information required by the Agency for approval of the Gencaro NDA.
AMAG Pharmaceuticals, a United States-based pharmaceutical company, has received a
complete response letter for its application seeking approval for a single-dose vial of Makena (hydroxyprogesterone caproate injection) from the United States Food and Drug Administration, it was reported yesterday.
9% of the patients achieved a
complete response (using EBMT criteria) and 73.
CHICAGO -- Biogen Idec (NASDAQ: BIIB) announced today that data presented at the 43rd American Society of Clinical Oncology (ASCO) annual meeting showed that adding Zevalin([R]) (Ibritumomab tiuxetan) radioimmunotherapy to a short course first-line treatment followed by rituximab weekly for four weeks doubled the rate of
complete response in patients with follicular lymphoma, from 44 percent with a standard treatment regimen to 88 percent.
M2 EQUITYBITES-December 30, 2013-Genzyme announces receipt of
Complete Response Letter from US FDA on supplemental Biologics License Application for Lemtrada
M2 PHARMA-January 22, 2013-Impax Pharmaceuticals gets FDA's
complete response letter for RYTARY's NDA(C)2013 M2 COMMUNICATIONS
When added to the FCR regimen, lumiliximab demonstrated a 52 percent
complete response (CR) rate in patients who have CLL that was progressing after prior therapy.
M2 EQUITYBITES-September 9, 2013-Endo Pharmaceuticals submits
complete response to new drug application for AVEED(C)2013 M2 COMMUNICATIONS http://www.
M2 PHARMA-September 10, 2012-Janssen Research & Development LLC submits
complete response for XARELTO(C)2012 M2 COMMUNICATIONS
