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21 C.F.R. § 314.161

Section 314.161 - Determination of reasons for voluntary withdrawal of a listed drug
Section 314.161 - Determination of reasons for voluntary withdrawal of a listed drug

1 Citing brief

  1. State of Wisconsin et al v. Indivior Inc. et al

    MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM , MOTION to Dismiss for Lack of Jurisdiction

    Filed December 12, 2016

    103 In this case, there have been thousands of accidental exposures to children causing severe adverse events including hospitalization and death. RBP now has evidence showing that when buprenorphine for opioid addiction is packaged in child-resistant unit-dose, versus multi-dose packaging, the risks of pediatric 102 103 21 C.F.R. § 314.127(a)(ll); FDC Act§ SOSG)(4)(I). 21 C.F.R. § 314.161(A)(l). Case 2:16-cv-05073-MSG Document 141-6 Filed 12/12/16 Page 44 of 49 Division of Dockets Management September 25, 2012 Page 44 exposure are significantly reduced. In response to these findings, RBP discontinued marketing of Suboxone tablets (NDA 20-733).