Ciba Corp. v. Weinberger

Petitioner manufactures a drug called Ritonic Capsules † for which it filed a new drug application (NDA) that became effective in 1959. Under the Act then in force, an NDA for a “new drug” required the manufacturer to submit to the Food and Drug Administration (FDA) adequate proof of the drug's safety. This particular NDA became effective on the basis of the drug’s safety. As we have noted in the companion cases, the 1962 amendments to the Federal Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1040, as amended, 76 Stat. 780, directed FDA to withdraw approval for NDA’s which became effective…