About 12 months ago, AbbVie filed a Citizen Petition asking the FDA to take certain steps to tighten and clarify its procedures for making interchangeability determinations. Earlier this year, both Sandoz and GPhA urged the FDA to deny the petition.
Today, the FDA posted an interim response on the docket (FDA-2015-P-4935) indicating that it “has been unable to reach a decision on [AbbVie’s] petition because it raises complex issues requiring extensive review and analysis by Agency officials.” The FDA states that it “will respond to [AbbVie’s] petition as soon as [it] ha[s] reached a decision on [AbbVie’s] request.”
The FDA’s letter comes on the heels of conflicting reports about when the FDA will issue its long-awaited draft guidance on interchangeability, which still remains uncertain.
Stay tuned to the Big Molecule Watch for further developments.