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.

Mylan will market levothyroxine generics AB-rated to all three top brands following FDA approval of its bioequivalence claim to King's Levoxyl .

FDA approved a Mylan ANDA supplement July 13 that allows the product to be marketed as bioequivalent to, and substitutable for, Levoxyl.

Mylan is the only company approved to claim bioequivalence to Abbott's Synthroid , Jerome Stevens' Unithroid and Levoxyl. ANDAs for Mylan generics AB-rated to Synthroid and Unithroid were previously cleared (¹ (Also see "Synthroid, Levoxyl Generics Clear FDA; Sandoz Has Broadest Line" - Pink Sheet, 24 Jun, 2004.)).

Mylan's Levoxyl generic will compete with Alara's Levo-T and Unithroid for King's levothyroxine market share. Levo-T and Unithroid were approved as equivalent to Levoxyl June 23.

Mylan had hoped to receive 180-day generic marketing exclusivity for its Levoxyl equivalent. The company had previously filed a full ANDA with a Paragraph IV certification to a King patent and was sued by King, thereby triggering a 30-month stay of ANDA approval.

FDA later allowed Jerome Stevens and Alara to file supplemental NDAs without patent certifications. Mylan said it was informed by FDA after those sNDAs were approved that it, too, could file a supplement to its previously approved ANDA.

Mylan objected to FDA's treatment of the Jerome Stevens and Alara applications and sided with King in its lawsuit challenging the agency's approval of Levoxyl bioequivalence claims.

A D.C. federal judge denied King's request for a temporary restraining order and injunction (² (Also see "King Denied Injunction In Levothyroxine Suit Against FDA; Mylan Faces Exclusivity Loss" - Pink Sheet, 7 Jul, 2004.)).

- Catherine Harrison