We are encouraged by the feedback received from the FDA in the complete response
and appreciate the clarity around the path forward for AVEED," said Ivan Gergel, executive vice president of research and development and chief scientific officer of Endo Health Solutions.
Assess the impact that an advisory committee vote is likely to have on approval and the probability that a Complete Response
Letter will be issued.
According to the criteria, a complete response
is obtained when there is a complete disappearance of all detectable clinical and radiographic evidence of disease and disease related symptoms, all lymph nodes have returned to normal size, the spleen has regressed in size, and the bone marrow is cleared of lymphoma.
Pfizer is working to understand and address the issues in the FDA Complete Response
Letter," said Olivier Brandicourt, Pfizer President and General Manager, Primary Care.
Based on these interactions, we believe we have addressed all requirements of the 2009 Complete Response
Such forward-looking statements include statements about future activities related to the complete response
letter regarding the company's new drug application for Linjeta(TM); the company's response to the complete response
letter; the importance of the complete response
letter; and the company's focus, goals, strategy, research and development programs, and ability to develop and commercialize product candidates.
Pharma received a Complete Response
Letter from the FDA regarding its New Drug Application submitted in May 2009.
Food and Drug Administration (FDA) has issued a Complete Response
Letter (CRL) requesting additional information regarding the company's new drug application (NDA) for Linjeta(TM) (human insulin [rDNA origin]) injection 100IU/mL for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control.
Nasdaq:APPA), a specialty pharmaceutical company, today announced that it received a Complete Response
Letter from the U.
today announced that the Company has received a complete response
letter from the U.
Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that the company has received a Complete Response
Letter from the U.
In a clinical study conducted in Italy involving 41 patients (44 nodes) with inoperable Stage IV head and neck cancer, patients receiving hyperthermia and radiation therapy had an 83% complete response
rate compared to 41% for patients who received radiation therapy alone, and the 3-year local relapse-free survival rate was 24% for patients receiving only radiation and 68% for those who received both radiation and hyperthermia therapy.