制药提价与抑制仿制药方式 472条(本栏目收费,不能显示细节,电话13136136841)
purpose and complexity of, 26 26
Actavis (drug company) FTC v. Actavis and, 24, 43,45, 49,50, 65 65
product hopping of Namenda to Namenda XR, 76,78 78
FDA attempts to curb abuse of, 97,98 98
FDA denial rates of, 94 94
In re Suboxone case and, 95,97 97
Mutual Pharmaceuticals ‘orange juice’petition, 92,94 94
number of filed since 2007 amendments, 98,99 99
original purpose of, 113 113
pharmaceutical company use of for generic delay, 91, 92 92
Section 505(q) amendments and, 97,98 98
sham citizen petitions assertions, 99,100 100
staggered petitions for Doryx by Warner Chilcott, 100,102 102
summary denial provision via 505(q) amendment, 99, 134 134
citizen petitions as delay tactic, 25, 91, 92, 131 131
by AstraZeneca for Crestor, 108,110, 111,112 112
compilation of documents related to empirical analysis, 116 116
effectiveness of 2007 FDA amendments and, 128,131 131
empirical evidence of rise in petitions with 0
potential to delay generic applications,99, 122,123 123
by Endo for Opana, 94,95 95
filing dates for generic applications and, 119,120 120
identifying petitions that delay entry, 117,118 118
key findings from empirical analysis of,113,115, 122 122
key metrics in, 121,122 122
by King Pharmaceuticals for Skelaxin, 105,108 108
Provigil (narcolepsy drug, Teva), 47,48, 51, 57,59 59
In re Lipitor case of, 53,56 56