Landmark Publications

New Drug Applications Landmark Publications

THIS CASEBOOK contains a selection of U. S. Court of Appeals decisions that analyze and discuss issues stemming from new drug applications filed with the U. S. Food and Drug Administration. * * * Prescription drugs in the United States must be approved by the Food and Drug Administration (FDA) before they can be sold. 21 U. S. C. § 355(a). Prospective drugs can follow one of two general paths to obtain FDA approval. A new drug that has never been marketed before must be approved through the new drug application (NDA) process. The NDA process requires an extensive series of safety and effectiveness trials before a new drug can be sold. See § 355(b)(1). * * * If the prospective drug is "the same as" an existing drug already on the market, however, the maker can obtain approval through the shorter and less onerous abbreviated new drug application (ANDA) process. See § 355(j)(2)(A). The ANDA process requires proof that the drug in question has the same active ingredients, effects, and labeling as a predecessor drug that the FDA has already approved. Id.; 21 C. F. R. § 314.94(a) (2015). The predecessor drug that has already received FDA approval is known as the reference listed drug (RLD). 21 C. F. R. § 314.3(b). In many cases, the reference listed drug is the original drug that pioneered a new active ingredient or a new treatment and gained FDA approval through the new drug application process. If the original pioneer drug has been discontinued, the FDA will typically designate the remaining market-leading drug to take its place as the reference listed drug for that particular category of drugs. [A state law failure-to-warn claim against the manufacturer of a generic drug approved under an ANDA is preempted by federal law - Affirmed.] Guilbeau v. Pfizer Inc., (7th Cir. 2018).