Amylin's Symlin US approval on hold
The US Food and Drug Administration has issued a second approvableletter for Amylin Pharmaceuticals' Symlin (pramlintide acetate), the company's lead drug candidate in development for the treatment of diabetes.
The agency has requested further clinical data to identify a patient population and method of use for Symlin where there is no increased risk of significant hypoglycemia or where there is an added benefit that clearly counterbalances any potential for increases in episodes of hypoglycemia, noted the company.
Amylin said in a statement that it believes existing data obtained since the filing of the amended New Drug Application for Symlin in June this year could provide the information requested by the FDA. The company first submitted an NDA in the USA at the end of 2000 (Marketletters passim).
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