PharmaRoth Labs, Inc., formerly Fero Industries, Inc., announced that the Food and Drug Administration (FDA) has reclassified its diabetes agent, Sucanon, as a drug. The FDA decided that the reclassification from neutraceutical to drug was appropriate due to the profile of the active ingredient. The company’s leading product is for type 2 diabetes. The FDA is responding to PharmRoth’s New Dietary Ingredient (NDI) Application, filed in March of 2013.
Luis Lopez, CEO of PharmaRoth, said, "We are very satisfied with the FDA's determination, as we have always felt that Sucanon was a drug. Now that the FDA agrees with our findings, it is actually a very positive thing for the product going forward: a 'drug' designation by the US FDA has large beneficial implications on an international level.”
According to FDA standards, if a therapeutic agent originates from natural sources, it may be considered a neutraceutical or dietary supplement. Under the Food, Drug, and Cosmetic Act (the FD&C Act), to market these products, sponsors must adhere to New Dietary Ingredient (NDI) regulations and procedures. Under these rules, a “new dietary ingredient” is an ingredient not marketed in the U.S. as a dietary supplement before October 15, 1994.
Additionally, the dietary ingredient must be a vitamin, mineral, herb, or botanical. It may also be an extract of those substances, a concentrate, metabolite, constituent, or combination of any of those substances. Interested parties can view the specifics in the FD&C Act, section 201(ff).
The FDA reviewed PharmaRoth’s NDI and concluded that Sucanon’s active ingredient would be inappropriately classified as a neutraceutical. The application was therefore denied. The company must now revise its strategy and submit an Investigational New Drug (IND) application before being available in the U.S.
Sucanon is a treatment for type 2 diabetes, in a class of agents known as insulin sensitizers. It works by increasing liver, fat, and muscle sensitivity to insulin, thereby lowering blood sugar levels. Clinical trials in Brazil and China showed favorable results. Patients in Peru may obtain the drug by prescription and in Mexico over the counter.
PharmaRoth Labs Inc. changed its name from Fero Industries, Inc. The company holds all rights to Sucanon. It is marketing the drug in Mexico in partnership with Merck.