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# Reject Some Potassium Chloride ANDAs: Par
- URL: https://www.fdaweb.com/reject-some-potassium-chloride-andas-par/
- Published: 2016-04-07T12:00:00.000Z
- Updated: 2026-09-14T20:53:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135303

> Par Pharmaceuticals is asking FDA not to approve any ANDA for a potassium chloride oral solution drug product for use in certain pediatric patients if the proposed product contains alcohol as one of its components. The company’s 3/22 [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-1073-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) specifically asks that the agency:  
> refrain from approving any ANDA for a potassium chloride oral solution drug product for pediatric patients if the proposed generic product includes alcohol as an inactive ingredient; and refrain from approving any ANDA submitted by Pharmaceutical Associates, Inc., seeking approval of a product with the Pharma-Med NDA marketed by Par as Par KCI Oral Solution as its reference-listed drug if the proposed drug product includes alcohol as an inactive ingredient, and instead require submission of a 505(b)(2) NDA.  
>  
> The petition says that the prescribing information for Par KCI Oral Solution includes pediatric patients from birth to age 16 for treating hypokalemia and for maintenance or prophylaxis. It notes that its product does not contain alcohol and says that the inclusion of alcohol would present an unnecessary risk to pediatric populations because it is unsafe in those populations.  
>  
> “Physicians, academics, and regulators uniformly warn against the use of alcohol in children’s drug products,” Par says. “The safe dose of alcohol in children is not known and cannot be investigated in controlled clinical trials due to ethical concerns of doing such studies in children. Children can be given multiple oral drugs with alcohol, and the total alcohol exposure may be much greater than what is included in a single medicine…. Alcohol is not inactive, but is a pharmacologically active excipient that causes CNS, CVS, liver toxicity, and has a variety of activities across pharmacologic receptors such as dopamine and serotonin receptors, the HPA axis, and the central adrenergic system. Children are generally considered to be more sensitive to alcohol effects, and in general are expected to have different PK, PD, and metabolic reactions to alcohol in comparison to adults.”