Le Lézard
Classified in: Health
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® (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 

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.


These press releases may also interest you

at 16:50
VANCOUVER, Oct. 21, 2017 /CNW/ - For many Canadians, experiencing trauma has a major impact on their lives and plays a role in their problematic substance use. Sex and gender are also important factors in understanding and treating individuals for...

at 09:00
VANCOUVER, Oct. 20, 2017 /CNW/ - The Honourable Ginette Petitpas Taylor, Federal Minister of Health, will announce additional support for the BC Centre of Excellence for Women's Health through Health Canada's Substance Use and Addictions Program to...

at 09:00
VANCOUVER, Oct. 20, 2017 /CNW/ - The Honourable Ginette Petitpas Taylor, Federal Minister of Health, will mark the one-year anniversary of the Healthy Eating Strategy by highlighting the progress that has been made to date during her keynote address...

at 00:15
HUNTINGTON BEACH, Calif., Oct. 21, 2017 /PRNewswire/ -- Wavelengths Recovery was a proud sponsor of "Chasing the Dragon - Opioid Awareness Community Event" held on Oct. 18. This event was held at the City National Grove of Anaheim. Many members of...

20 oct 2017
VANCOUVER, Oct. 20, 2017 /CNW/ - The Honourable Ginette Petitpas Taylor, Federal Minister of Health, will announce additional support for the BC Centre of Excellence for Women's Health through Health Canada's Substance Use and Addictions Program to...

20 oct 2017
Product photos are available at http://bit.ly/2hSM8qr OTTAWA, Oct. 20, 2017 /CNW/ - Hen Long Oriental Gifts and Foods Co. Ltd. is recalling Captain's Choice brand Frozen Shrimp Shaomai from the marketplace because it contains egg which is not...




News published on 5 october 2017 at 11:57 and distributed by: