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Open for comment Health and Human Services Department, Food and Drug Administration Docket Docket Nos. FDA-2025-E-3595 and FDA-2025-E-3596

FDA Determines Regulatory Review Period for Andembry to Support Patent Extension

💬 Comments close in 126 days (Mar 8)

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  1. Proposed / opened

    FDA Determines Regulatory Review Period for Andembry to Support Patent Extension

  2. Related document

    Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY

Briefs in this proceeding

Notable FDA 💬 Comments close in 126 days (Mar 8)

FDA Determines Regulatory Review Period for Andembry to Support Patent Extension

FDA's determination of the regulatory review period for Andembry enables patent term restoration under the Hatch-Waxman Act, directly impacting commercial exclusivity for this biological product. The Food and Drug Administration (FDA) has determined the regulatory review period for Andembry, a...

Sources

Health and Human Services Department, Food and Drug Administration · Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY · Sep 9