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# McGuff NDA for Ascor Approved by FDA
- URL: https://www.fdaweb.com/mcguff-nda-for-ascor-approved-by-fda/
- Published: 2017-10-05T12:00:00.000Z
- Updated: 2026-09-14T22:54:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139800

FDA has approved a McGuff Pharmaceuticals NDA for Ascor (ascorbic acid injection USP), a vitamin C drug product for the short term (up to one week) treatment of scurvy in adult and pediatric patients aged five months and older for whom oral administration is not possible, insufficient or contraindicated. The product is not indicated for treating vitamin C deficiency that is not associated with scurvy, the company notes. On the safety side, the approved labeling warns that ascorbic acid has been associated with development of acute or chronic oxalate nephropathy following prolonged use of high doses of ascorbic acid infusion. “Patients with renal disease including renal impairment, history of oxalate kidney stones, geriatric patients, and pediatric patients less than two years old may be at increased risk,” the company says.