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Table 2A: GLM Analysis of Postmarket Dosage-Form Discontinuation for Standard NMEs Standard Errors in Parentheses ; Variables Linear Mixed Effects Model Linear All Fixed Effects Model Linear Fixed Effects Model post-1962 ; Year of Submission -0.0000 -0.0000 -0.0003 0.0001 ; 0.0001 ; 0.0002 ; Approval in First Six Months 0.0005 0.0084 ; Approval in 9th or 10th Month, pre-PDUFA -0.0011 0.0003 - 0.0075 ; 0.0080 ; Approval in 11th or 12th Month, pre-PDUFA 0.0065 0.0067 - 0.0072 ; 0.0076 ; Approval in 13th or 14th month, pre-PDUFA 0.0021 0.0015 - 0.0074 ; 0.0078 ; Approval in 11th or 12th Month, PDUFA 0.0641 0.0643 0.0430 [pre-deadline] 0.0132 ; 0.0143 ; 0.0119 ; Approval in 13th or 14th Month, PDUFA 0.0298 0.0332 -[post-deadline] 0.0160 ; 0.0169 ; Approval in 9th or 10th Month, FDAMA 0.0852 0.0769 0.0633 [pre-deadline] 0.0151 ; 0.0173 ; 0.0162 ; Approval in 11th or 12th Month, FDAMA -0.1035 -0.1033 -[post-deadline] 0.0199 ; 0.0214 ; Number of Indicator Variables for Sponsors 49 0 Number of Effects Terms for Primary 194 178 Indication [random] [fixed] [fixed] NMEs 1, 304 1, R-squared 0.1336 0.1230 0.0430 Corr ui, Z ; Assumed 0 -0.0205 0.0424 Joint Significance of Primary Indication -F 193, 1054 ; 1.41 F 177, 756 ; 1.36 Terms p 0.0005 ; p 0.0033 ; Joint Significance of Firm Indicators Chi-sq 102.29 F 48, 1054 ; 1.88 - p 0.0001 ; p 0.0003.

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