McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuffCompany, Inc. announces the United States Food and Drug Administration’s New Drug Approval (NDA) of Ascor (Ascorbic Acid Injection, USP). Ascor is provided in a 50 mL vial labeled as a Pharmacy Bulk Package with a strength of 500mg/mL.
Ascor is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.
Ascor is the first single moiety ascorbic acid drug approved for the US market and is the result of a multi-year development effort.
Ronald McGuff, CEO said "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. In addition, McGuff Pharmaceuticals, Inc. currently
holds Ascorbic Acid Injection USP approvals in multiple other
countries."
McGuff Pharmaceuticals, Inc. is building a new 86,000 ft2 manufacturing facility in Santa Ana, Orange County, California to manufacture both branded and contract labeled sterile pharmaceutical products.
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