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Mylan/King Merger Brings Another Twist To Levothyroxine Generics

This article was originally published in The Pink Sheet Daily

Executive Summary

Mylan's launch of a generic version of the thyroid hormone levothyroxine will not be affected by the proposed acquisition of Levoxyl-manufacturer King Pharmaceuticals, Mylan maintained during a July 26 conference call

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Mylan Levoxyl Generic Clears FDA As ANDA Supplement

Mylan is the only company cleared to market generics equivalent to all three market-leading levothyroxine brands: Synthroid, Unithroid and Levoxyl. Mylan’s Levoxyl generic will compete with Levo-T and Unithroid for King’s levothyroxine market share.

King Denied Injunction In Levothyroxine Suit Against FDA; Mylan Faces Exclusivity Loss

A D.C. federal judge declines to stay or temporarily revoke FDA approval of supplemental NDAs allowing Alara’s Levo-T and Jerome Stevens’ Unithroid to claim equivalence to Levoxyl. Mylan also is protesting FDA approval of the supplemental NDAs because the company believes it is entitled to 180-day generic exclusivity for Levoxyl.

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.

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