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Manufacturer of Symlin Submits Complete Response to FDA
SAN DIEGO, Sept. 20 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. today announced the submission of a complete response to the U.S. Food and Drug Administration's second approvable letter for SYMLIN® (pramlintide acetate). Resubmission of a complete response after receipt of an approvable letter is intended to answer all of the questions that need to be addressed prior to approval. The FDA is expected to respond to this new submission within six months.
"Based on numerous discussions with the FDA, we believe that data generated since our last SYMLIN® submission in June 2003 and additional analyses of earlier studies, including the pivotal studies, answer the questions raised in the second approvable letter," said Ginger L. Graham, President and CEO of Amylin Pharmaceuticals, Inc.