The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday issued a final guidance to assist sponsors interested in developing nicotine replacement therapy drug products (NRT) products to help patients stop smoking.
The agency said the amount of data required to support the approval of an NRT product will depend on whether it is a generic version of an approved drug, or how similar a new drug is to an already approved product. The agency said it anticipates that most sponsors will submit these types of products under the abbreviated new drug application (ANDA) pathway or the 505(b)(2) pathway that enables sponsors to rely on the agency’s findings of safety and effectiveness for an approved product…
