FDA Sets Limits On Public Comment Process In Levothyroxine Generic Approvals
This article was originally published in The Pink Sheet Daily
Executive Summary
Abbott does not have the right to demand an advisory committee meeting or a public workshop on levothyroxine issues before generic approvals, FDA told the company
You may also be interested in...
Generic Synthroid Approval Relies On Abbott Bioequivalence Methodology, FDA Says
FDA rejects Abbott’s critique of its bioequivalence methodology and denies citizen petitions to stay levothyroxine generics. Methods used in approving NDAs should be acceptable for generic approvals, FDA says.
Generic Synthroid Approval Relies On Abbott Bioequivalence Methodology, FDA Says
FDA rejects Abbott’s critique of its bioequivalence methodology and denies citizen petitions to stay levothyroxine generics. Methods used in approving NDAs should be acceptable for generic approvals, FDA says.
Synthroid, Levoxyl Generics Clear FDA; Sandoz Has Broadest Line
Mylan receives the first ANDA approval for Abbott’s market-leading levothyroxine brand Synthroid. Sandoz, through a partnership with Mova, will market a levothyroxine tablet rated bioequivalent to both Synthroid and King’s Levoxyl. The approvals follow FDA’s decision to reject an Abbott citizen petition.