Filed February 3, 2017
Case 1:16-cv-01350-RBW Document 34 Filed 02/03/17 Page 49 of 61 37 The foregoing statutory provisions are fully consistent with others that expressly require a hearing in connection with restrictions upon, or withdrawal of, drug approvals โ even for the most serious regulatory compliance concerns. See 21 U.S.C. ยง 335c(a)(1), 335c(b) (hearing required before withdrawing ANDA approval on the ground that it was โobtained, expedited, or otherwise facilitated through bribery, payment of an illegal gratuity, or fraud or material false statementโ); 21 U.S.C. ยง 355(e) (hearing required in connection with suspension of drug approval on the ground that there is an โimminent hazard to the public healthโ); 21 U.S.C. ยง 360b(e) (hearing required in connection with suspension of animal drug approval on the ground that there is an โimminent hazard to the health of man or of the animals for which such drug is intendedโ). 3.
Filed April 30, 2010
- consult the Green Book and include in its abbreviated new animal drug application (โANADAโ) a certification regarding any listed patent on which it is basing its ANADA (indicating whether the patent is still in effect or expired). See, e.g., 21 U.S.C. ยง 360b(n)(1)(H). In Merialโs case, the Green Book explicitly disclosed the expiration date of the โ569 Patent when the patent issued, and it tracked all changes in the patentโs expiration date as the law changed and as patent owner Merck sought various patent term extensions for the patent.