FDA Clears Injectable Ascorbic Acid (Ascor) for Scurvy
The US Food and Drug Administration (FDA) has approved ascorbic acid injection USP (Ascor, McGuff Pharmaceuticals, Inc), the company has announced.
Ascor (vitamin C) is indicated for the short-term (up to 1 week) treatment of scurvy in adults and children aged 5 months and older for whom oral administration is not possible, is insufficient, or is contraindicated.
Ascor is not indicated for the treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.
Ascor consists of a 50-mL pharmacy bulk package of sterile, preservative-free, pyrogen-free ascorbic acid USP (500 mg/mL) in a solution containing edetate disodium (0.025%), water for injection (qs), and sodium bicarbonate for pH adjustment (pH 5.6 - 6.6).
Although storage conditions for ascorbic acid injection are not specified in the USP, McGuff Pharmaceuticals recommends that Ascor be refrigerated and protected from light.
"Ascor is the first single moiety ascorbic acid drug approved for the US market and is the result of a multi-year development effort," the company said in a news release.
"The FDA approval of Ascor Ascorbic Acid Injection USP will allow McGuff Pharmaceuticals, Inc. to deliver this medically necessary drug to US hospitals and pharmacies to improve patient health," company CEO Ronald McGuff said in the release. The company currently holds ascorbic acid injection USP approvals in several other countries.
SOURCE: Medscape, October 09, 2017.