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# Require 2-Bag Dosing Reference in Acetadote Generics: Petition
- URL: https://www.fdaweb.com/require-2-bag-dosing-reference-in-acetadote-generics-petition/
- Published: 2025-11-12T12:00:00.000Z
- Updated: 2026-09-14T15:26:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160205

Cumberland Pharmaceuticals has petitioned FDA to decline to accept or approve any ANDAs or 505(b)(2) applications that cite its Acetadote (acetyleysteine) as the reference-listed drug with labeling that omits the branded prescribing information relating to a two-bag dosing regimen. The company’s [petition](The%20document%20is%20a%20citizen%20petition%20from%20Cumberland%20Pharmaceuticals%20Inc.%20requesting%20the%20FDA%20to%20require%20labeling%20of%20generic%20drug%20products%20referencing%20ACETADOTE%20to%20include%20essential%20safety%20information%20about%20a%20two-bag%20dosing%20regimen%20that%20reduces%20the%20risk%20of%20hypersensitivity%20reactions.) also asks that any approved ANDAs referencing Acetadote be converted to tentative approvals until the 11/2027 expiration of the three-year exclusivity protecting information relating to the two-bag regimen.

Acetadote is an antidote for acetaminophen overdose and has a two-bag dosing regimen that was approved by the agency in 11/2024 to reduce the risk of hypersensitivity reactions compared to a three-bag regimen. The petition says the two-bag regimen is associated with significantly lower incidence of hypersensitivity reactions compared to the three-bag regimen.

Cumberland says that an FDA decision on Rapamune (sirolimus) labeling regarding hypersensitivity “supports the inclusion of critical dosing information for Acetadote to mitigate risks associated with hypersensitivity reactions.”

The petition asks FDA for a prompt response “because it raises an important safety issue concerning the labeling of currently approved and marketed generic products, in addition to potential future generic and 505(b)(2) products.”