Assertio Therapeutics announced that it has received notification of acceptance for filing from the FDA for its 505 new drug application for its injectable formulation of long-acting cosyntropin. The company, together with its partner West Therapeutic Development, seeks approval for the use of this product as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency. The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of long-acting cosyntropin is set for October 19. This date reflects a standard 10-month review period and is consistent with management’s expectations for the 505 filing.
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