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# FDA May Allow Novel Carve-Ins: Attorneys
- URL: https://www.fdaweb.com/fda-may-allow-novel-carve-ins-attorneys/
- Published: 2024-07-31T12:00:00.000Z
- Updated: 2026-09-14T14:36:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157479

Axinn attorneys **Matthew Murphy** and **Aaron Savit** say a recent regulatory decision on a generic form of Novartis’ chronic heart failure drug Entresto (sacubitril/valsartan) may signal some agency flexibility to consider novel carve-in labeling modifications as part of a Section viii skinny labeling strategy. Writing in an online [post](https://www.jdsupra.com/legalnews/fda-expands-practice-of-permitting-5751394/?ref=fdaweb.com), the attorneys say that based on a later study following the drug’s approval, FDA approved an expanded patient population. The agency denied a petition asking that FDA not approve any ANDA seeking to exclude the newly added patient population using Section viii statements.

At least one ANDA filer has already been approved with such a carve-in, the attorneys say. They say the agency approach is consistent with an earlier decision involving a carve-in for a generic form of Takeda’s Velcade (borezumib).