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Synthroid, Levoxyl Generics Clear FDA; Sandoz Has Broadest Line

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Levothyroxine Bioequivalence To Be Discussed At FDA Public Meeting

Scheduling the event suggests FDA is re-evaluating its position on the interchangeability of the drug class. Announcement of the May 23 meeting comes nearly one year after the agency approved a number of equivalence claims for levothyroxine sodium products.

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