Drugs

Risk Assessments Sought for Potassium Chloride Products

Vertice Pharma, which markets an FDA-approved potassium chloride oral solution, is asking that the agency refuse to receive drug applications seeking approval of certain potassium chloride drug products and refrain from approving any pending applications for such products that do not have a complete risk assessment and appropriate controls for elemental impurities.

The company petition says it is directed to all pending and subsequently submitted drug applications for potassium chloride oral drug products for human use.

Vertice says it wants FDA to:

refrain from filing for review any NDA, or from receiving any ANDA, unless the application includes summaries of completed risk assessments in accordance with the International Conference on Harmonization Q3D guidance and appropriate controls as needed for these elemental impurities in the product: lead, arsenic, cadmium, mercury, chromium, copper, selenium, manganese, zinc, and metals that are present during the manufacturing process and have the potential to contaminate the proposed product; and
refrain from approving 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.

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