Historical Highlights of ASCOR® Ascorbic Acid Injection (Vitamin C Injection)

Ascorbic Acid Injection (vitamin C) is one of the vital therapies that has been used for decades to address severe vitamin C deficiency and other medical conditions.

McGuff is Committed to Preserving Patient Access to Ascorbic Acid Injection

At McGuff Pharmaceuticals, Inc. (MPI), our mission is rooted in ensuring that essential medical treatments remain accessible to the people who need them.

Our desire to secure the first FDA approval for ASCOR® (Ascorbic Acid Injection) was driven by a steadfast commitment to patient access to safe and effective treatments.

A Timeline of Dedication: The Story of ASCOR

• 1928: Albert Szent-Györgyi isolated ascorbic acid, paving the way for its medical applications.
• Mid-20th Century: Ascorbic Acid Injections became widely used in alternative and complementary clinical settings.
• 1979: McGuff first started selling Ascorbic Acid Injections
• 1999: McGuff Compounding Pharmacy Services established to produce and supply physicians with branded, non-corn Ascorbic Acid Injections
• 2002: McGuff Pharmaceuticals, Inc. established to supply commercially manufactured Ascorbic Acid Injections
• 2006: FDA gave notice it did not believe Ascorbic Acid Injections, marketed as a grandfathered drug, met the requirements of grandfathered drugs. McGuff understood the FDA would stop the manufacturing of Ascorbic Acid Injections. McGuff consulted with the FDA to obtain a New Drug Application Approval; the first in the United States.
• 2007: The Office of Orphan Products Development granted orphan designation for Ascorbic Acid Injection for the treatment of scurvy.
• 2010: FDA took action and stopped the manufacture of all commercially available Ascorbic Acid Injections in the United States.
• 2016: McGuff Pharmaceuticals, Inc. submitted the New Drug Application (NDA) for ASCOR (Ascorbic Acid Injection) to the FDA.
• 2017: The FDA approved the NDA submission for ASCOR, ensuring its continued availability and expanding its use in clinical trials.

The Early Role of Ascorbic Acid Injection in Medicine

Ascorbic acid, better known as vitamin C, was first isolated in 1928 by Nobel Prize winner, Albert Szent-Györgyi. Recognizing its potential, the medical community quickly began exploring its applications beyond dietary supplementation. Injectable vitamin C emerged as a crucial treatment for conditions where high doses were necessary, such as in severe cases of scurvy.

Throughout the mid-20th century, Ascorbic Acid Injection became a trusted therapy in clinical settings. It provided a reliable means of delivering vitamin C directly into the bloodstream, offering rapid correction of deficiencies and serving as a supportive therapy in various medical conditions. McGuff first started selling its Ascorbic Acid Injection in 1979, which progressed to McGuff Pharmaceuticals, Inc. producing it in 2002. However, as the regulatory environment evolved, the continued availability of such treatments required formal FDA approval.

Securing the Future of Ascorbic Acid Injection

Understanding the importance of regulatory compliance and the potential risks to patient access, McGuff took proactive steps to ensure that Ascorbic Acid Injection would remain available. On August 31, 2007, the Office of Orphan Products Development (the division that supports and advances the development and evaluation of new treatments for rare diseases) granted Ascorbic Acid Injection an orphan designation for the treatment of scurvy, recognizing its critical role in addressing this rare but serious condition.

Working closely with the FDA, McGuff, submitted a New Drug Application (NDA) for ASCOR (Ascorbic Acid Injection). This involved extensive collaboration with the FDA and conducting the necessary clinical trials to support our submission. On September 2, 2016, we formally submitted the NDA, marking a significant step in our efforts to preserve access to this essential treatment.

ASCOR – Superior Quality by Design

It’s worth noting that ASCOR, our ‘injectable vitamin C’, was designed and developed with superior raw materials, special processes to eliminate known potential allergens and produced preservative-free for safer long-term use.

ASCOR does not include any:

• GMOs
• Dyes
• Fillers
• Preservatives, or
• Detectable corn allergens

ASCOR is proudly manufactured in the USA by McGuff Pharmaceuticals, a veteran-owned, family-owned, pharmaceutical manufacturer.

Watch this video to learn more about the benefits of ASCOR: 

FDA Approval: A Milestone in Patient Care

On August 31, 2017, our hard work, dedication and the consumption of 11 years of profits, culminated in the FDA’s approval of ASCOR Ascorbic Acid Injection (Vitamin C Injection). This approval was not just a regulatory milestone for MPI, it was a victory for patients and healthcare providers who rely on this treatment. With FDA approval, ASCOR is now recognized as a safe and effective therapy, ensuring that it remains available to those who need it most well into the future.

Our Ongoing Commitment to Patient Access

At McGuff Pharmaceuticals, Inc., our focus has always been on patient care and safety. By securing FDA approval for ASCOR, we have taken important steps to protect the availability of Ascorbic Acid Injection, safeguarding it from the uncertainties that unapproved drugs face in the current regulatory environment. We continue to manufacture ASCOR with the highest standards of quality, driven by our commitment to those who depend on this vital therapy.

The Future of ASCOR

As a company dedicated to the well-being of patients, we are extremely proud to have played a role in preserving access to Ascorbic Acid Injection with the original FDA-approved ASCOR. Our journey from orphan designation to FDA NDA approval reflects our unwavering commitment to ensuring that essential treatments like ASCOR remain available. ASCOR is the FDA’s Reference Listed Drug which sets the standard for all others to follow.

As we move forward, we remain steadfast in our mission to support patient health through the continued production of high-quality pharmaceutical products. We continue to innovate and support others to innovate using our drug products. MPI continues to participate financially in clinical trial research to help advance the treatment options for patients with other illnesses, injuries and diseases.

Learn more about the benefits of ASCOR and purchase vials for your practice.