AstraZeneca Pharmaceuticals LP v. FDA, et al

AstraZeneca, a manufacturer of pharmaceutical products, appealed from the district court's grant of summary judgment. AstraZeneca sought declaratory judgment that the FDA could not approve generic versions of its Seroquel product and sought to restrain the FDA from approving abbreviated new drug applications (ANDAs) for such competing products until the expiration of a period of exclusivity. As a preliminary matter, the court determined that its decision would affect AstraZeneca's actual rights and the case was not moot. On the merits, the court concluded that AstraZeneca's claims failed because the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301-99, only provided exclusivity for changes approved as part of a supplement. Because the FDA reasonably considered Table 2, a table summarizing previously submitted glucose data, as separate from the pediatric supplements, Table 2 was not a change approved in the supplement and therefore the statute did not entitle AstraZeneca to exclusivity for Table 2. Accordingly, the court affirmed the judgment. View "AstraZeneca Pharmaceuticals LP v. FDA, et al" on Justia Law