Abbreviated Drug Application Law and Legal Definition

Pursuant to 21 USCS § 321 (aa), [Title 21. Food And Drugs; Chapter 9. Federal Food, Drug, And Cosmetic Act; Definitions] the term abbreviated drug application means “an application submitted under section 505(j) [21 USCS § 355(j)] for the approval of a drug that relies on the approved application of another drug with the same active ingredient to establish safety and efficacy, and--

(1) in the case of section 306 [21 USCS § 335a], includes a supplement to such an application for a different or additional use of the drug but does not include a supplement to such an application for other than a different or additional use of the drug, and

(2) in the case of sections 307 and 308 [21 USCS §§ 335b, 335c], includes any supplement to such an application.”