FDA's approval of Sec. 505(b)(2) applications for Alara's Levo-T and Jerome Stevens' Unithroid claiming bioequivalence to King's Levoxyl appears to be appropriate, a D.C. federal court judge ruled.

Judge Reggie Walton denied King's motion for a temporary restraining order and preliminary injunction against FDA July 7.

King sued the agency June 28 for approving Levo-T and Unithroid supplemental new drug applications that lacked Paragraph IV certifications to an "Orange Book"-listed patent for Levoxyl (¹ [A#00660270004], p. 8).

The court agreed with FDA's argument that no Paragraph IV filing was necessary because the Alara and Jerome Stevens supplements did not rely on innovator data.

The "plain language of Sec. 505(b)(2) seemingly mandates this conclusion," the ² judge's opinion states.

"In assessing the persuasiveness of the FDA's position...the court finds significant the FDA's observation" that the original levothyroxine approvals - including King's Levoxyl approval - were based on publicly-available literature, the opinion states.

The court also said it "need not spend much time" on King's argument that FDA should have required Alara and Jerome Stevens to use the ANDA process, rather than the 505(b)(2) pathway, under FDA's own regulations and guidance.

The opinion notes that FDA regs state only that it "may" refuse to file a 505(b)(2) for a product open to approval under ANDA rules.

King's lawsuit cited FDA's June 2001 guidance on levothyroxine agents, in which the agency said it would not accept 505(b)(2) applications for levothyroxine after Aug. 14, 2001.

FDA responded that the referenced portion of the guidance concerned only initial NDA approvals and "has no applicability to NDA supplements, since it would be unnecessary and a waste of government resources to require" submission of full ANDAs, the judge noted. "The court finds this position persuasive."

King said it is considering its legal options in the case, including appealing the ruling.

Mylan is also assessing its options; the company was supporting King's lawsuit because it is claiming a right to 180-day exclusivity on its pending ANDA for a generic equivalent to Levoxyl.

In a June 30 amicus brief filed in the King suit, Mylan argued FDA should not have approved Alara's and Jerome Stevens' 505(b)(2) NDA supplements because the agency did not allow Mylan to pursue a similar approval process.

Mylan first received ANDA approval to market a levothyroxine generic (equivalent to Unithroid) in June 2002 (³ 'The Pink Sheet' June 17, 2002, In Brief).

On June 23, FDA also approved a Mylan ANDA for a generic of Abbott's Synthroid (⁴ [A#00660260001], p. 3).

In August 2002, Mylan attempted to file a supplemental ANDA for an "AB" rating to Levoxyl. FDA informed the company in January 2003 that it would need to file a separate, new ANDA to obtain such an approval, ⁵ Mylan's brief states.

Mylan said it filed a new ANDA, including a Paragraph IV certification to a King patent that was issued in April 2003. In doing so, the company believed it would receive 180-day generic exclusivity.

King sued Mylan for patent infringement in June 2003, triggering a 30-month stay of approval on its ANDA.

As a result, Mylan is now in the position of marketing an "AB" rated generic version of Unithroid - that in turn is "AB" rated to Levoxyl - though Mylan's generic is not.

Following the sNDA approvals for Alara and Jerome Stevens, Mylan said it was told by FDA that it could also obtain approval through a supplement.

"Placed in this quandary by the FDA, Mylan submitted such a supplement" in late June "based on FDA's assurance that final approval should be forthcoming shortly," the company said.

"Once again, however, Mylan's actions were to no avail and no approval was forthcoming."

FDA Levothyroxine Generic Approvals Upheld In First Court Challenge

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