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