Lack of product-specific guidance slows ANDAs: FDA study

In a retrospective study examining 400 drugs eligible for abbreviated new drug application (ANDA) filing between 2011 and 2017, FDA researchers identified 140 that had originally been approved as new chemical entities (NCEs). FDA noted that among the NCEs, “if market exclusivity resulted in annual revenues greater than $250 million for up to a 4-year period after the approval date, an ANDA submission for the given reference product was nearly four times more likely to be submitted than for a product generating sales of less than $10 million.” Brand-name drug products identified as complex were less likely to have generic submissions. Additionally, non-NCE drugs were almost four times more likely to have ANDA submissions if there was a published product-specific guidance available for the product. Researchers also found that “ANDA submissions occurred for more than half of the NCE products within the first 2 weeks after those ANDAs could be lawfully submitted.”