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Vitruvias Therapeutics Inc., and Sunny Pharmtech Inc., Announce the FDA Approval of Generic Aminocaproic Acid 500 mg and 1000 mg Tablets

Sunny Pharmtech, Inc., a Taiwan-based API and finished-dose drug development company, and Vitruvius Therapeutics Inc., an Auburn, Alabama-based generic drug company announced today that their Abbreviated New Drug Application (“ANDA”) for Aminocaproic Acid Tablets 500 mg and 1000 mg tablets has received final approval from the U.S. Food and Drug Administration.

Currently there are no marketed generic equivalents to Akorn Pharmaceuticals’ Amicar®.

The ANDA filing and approval was the result of an exclusive collaboration between Vitruvias and Sunny in the development, manufacturing and regulatory filing of Aminocaproic Acid tablets (500 mg and 1000 mg) for the U.S. market.

Aminocaproic Acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. The Aminocaproic Acid tablet is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required.

Carl Whatley, Vitruvias’s Chairman and CEO commented, “We are delighted to launch this product following an extensive collaboration with Sunny. This is Vitruvias’s second approval with Sunny, and the product plans to launch immediately. This approval also helps validate the proven capabilities of our partnership in bringing complex and difficult-to-manufacture products to market.”

Dr. Yon-Lian Wu, Sunny Pharmtech’s CEO and Chairperson, commented that “now there will be a second, more affordable option for these chronically ill U.S. patients, and payers will have an additional option to make this critical product available to a wider population of patients. For our young company it is a great achievement and it marks a significant milestone in our growth strategy.”

Whatley said, “The FDA approval of Aminocaproic Acid tablets, now offers an alternative to the current brand, Amicar®, with the same level of quality and efficacy, but at a reduced cost. We are proud to have achieved this milestone together, and will continue to work side-by-side to bring additional pharmaceutical options to U.S. patients and payors.”

About Sunny Pharmtech Inc.

Sunny Pharmtech Inc. is a specialty pharmaceutical company based in Taiwan and was founded in 2004 with a focus on the development of technically difficult products. In 2014, the capability of developing and producing active pharmaceutical ingredients was added. The resulting organization is now fully-integrated, doing research, development, and manufacturing on both API and finished-dose products, which includes orals, liquids, semi-solids, and parenterals.

About Vitruvias Therapeutics Inc.

Vitruvias is a generic pharmaceutical company which utilizes domestic and international partnerships to develop, manufacture, and market technically difficult generic products. Founded in 2013, the company’s primarily focus is on products in the generic sterile injectable market, semi-solid market, and selected high-value oral solids The Company received its first approval in September 2017, and anticipates additional approvals in late 2018 and early 2019.

Amicar® is a registered trademark of Akorn Pharmaceuticals

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Last Updated: 03-Dec-2018