Drugs

Petition Asks Potassium Chloride Actions

Vertice Pharma says FDA should not file for review any NDA or receive any ANDA for potassium chloride oral drug products unless the application includes summaries of completed risk assessment in according with an International Conference on Harmonization (ICH) Q3D guidance and appropriate controls as need for several elemental impurities in the product. The petition also asks that the agency not approve any pending NDAs or ANDAs until such risk assessments have been submitted to FDA and have been determined to be adequate, regardless of whether the application was submitted before or after 6/1/16. Vertice markets potassium chloride oral solution 20 mEq/15mL through one of its subsidiaries.

The petition says the company understands that FDA has sent notifications of postmarketing requirements related to elemental impurities to holders of certain approved NDAs for potassium chloride oral drug products. It says Vertice understands that the letters require the applicable NDA holders to conduct risk assessments in accordance with the ICH guidance and establish any needed controls for a number of metals that are present during the drug’s manufacturing process and have the potential to contaminate the drug.

“The safety determination that provided the statutory basis for issuing the letters also compels FDA to require safety assessments for elemental impurities before filing, receiving, or approving NDAs or ANDAs for potassium chloride oral drug products,” the petition says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome