Subject: FDA
McGuff Pharmaceuticals, Inc. Announces FDA Approval For Ascor® (Ascorbic Acid Injection USP)
SANTA ANA, Calif., Oct. 5, 2017 /PRNewswire/ -- McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuff Company, 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.
About Ascor®
Indication
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.
Limitations of Use
ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.
Important Safety Information
- 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 2 years old may be at increased risk.
- Patients with glucose-6-phosphate dehydrogenase deficiency are at risk of severe hemolysis; a reduced dose is recommended.
- Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing.
- Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid.
- Ascorbic acid may cause acidification of the urine and result in decreased amphetamine serum levels and affect excretion and plasma concentrations of other drugs sensitive to urine pH.
About McGuff Pharmaceuticals, Inc.
McGuff Pharmaceuticals, Inc. is a wholly owned subsidiary of McGuff Company, Inc. McGuff Pharmaceuticals is a Food and Drug Administration (FDA) inspected sterile fill manufacturer that maintains a tradition of quality and core competency in both FDA current Good Manufacturing Practices (cGMP) and International Organization for Standardization's Quality Management Systems 9001, a unique combination for any pharmaceutical manufacturer.
McGuff Pharmaceuticals currently manufactures both branded and generic injectables under its own label as well as providing contract manufacturing services, for distribution to key market segments, both domestically and internationally. MPI also offers contract clinical trial services and international import / export regulatory services.
About McGuff Companies
The McGuff family of companies consists of four US and one foreign corporation. All corporations are family held and veteran owned. McGuff Company, Inc. and subsidiaries provide the following diverse capabilities; aseptic drug manufacturing, medical products distribution and 3PL logistics, pharmacy compounded drugs and Canadian drug distribution.
For more information about Ascor® including approved package insert visit:
http://www.mcguffpharmaceuticals.com//About/Ascorbic-Acid-Injection.aspx
For more information about the McGuff family of companies visit:
www.mcguff.com
For more information on the FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective visit:
https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm
To report SUSPECTED ADVERSE REACTIONS, contact McGuff Pharmaceuticals Inc., toll free at 1-800-603-4795 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
SOURCE McGuff Pharmaceuticals, Inc.
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