Theophylline labeling guidance with "significant changes" from 1990 version issued by FDA.
THEOPHYLLINE PRODUCT LABELING "SIGNIFICANT CHANGES" are contained in a revised FDA guidance issued by the Office of Generic Drugs March 3. Generic manufacturers of the bronchodilator must return appropriately revised package insert labeling to the agency within 90 days or "at the time of next printing...whichever is sooner," a "Dear Applicant" letter accompanying the guidance states. The guidance was sent to 48 generic firms that hold ANDAs for theopylline and/or theophylline-related drug products.
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