Indoco Remedies and Novadoz Pharmaceuticals won U.S. Food and Drug Administration (FDA) approval of generic febuxostat in late December 2019. Febuxostat is the active ingredient in the gout medication Uloric.
Indoco and Novadoz both saw 40mg and 80mg febuxostat tablets approved by the FDA. The FDA considers a generic drug to be “the same as the brand-name drug in active ingredient, conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling.” Companies seeking FDA approval of generic drugs must demonstrate their drugs match the above criteria. They must also demonstrate their drugs are “bioequivalent” to the brand name drug. This means the drug arrives at the body part where it functions at the same time and in the same amount as the brand name drug. Generic drugs must also meet the same manufacturing and quality standards as the brand name drug.
Uloric is used for the treatment of gout. Gout is a painful type of arthritis which happens when the blood has too much uric acid in it. The gout occurs when the uric acid crystallizes. Genetics, diet and other health issues can cause this elevation of uric acid levels. Frequently eating seafood and meat, being overweight and drinking beer can increase the risk of gout.
Uloric made its way into the headlines in February 2019 when the FDA announced that the heart-related and overall death risks tied to taking Uloric are higher than the risks tied to taking allopurinol, an alternative gout drug. The FDA required that Uloric’s prescribing information contain a boxed warning about the risks. Boxed warnings are the FDA’s strongest and most prominent warnings.
The announcement came after Takeda Pharmaceuticals studied Uloric’s safety at the FDA’s mandate. 15 out of every 1,000 Uloric patients died from heart-related causes in the study. 11 out of every 1,000 allopurinol patients died from heart-related causes in the study. 134 out of 3,098 Uloric patients died from cardiovascular causes in the study. 100 out of 3,092 allpurinol patients died from cardiovascular causes in the study.
The FDA recommends that patients who experience any of the following side effects while taking Uloric immediately seek emergency medical care:
• Rapid or irregular heartbeat
• Chest pain
• Shortness of breath
• Severe and sudden headache
• Numbness or weakness in one side of the body
• Speech difficulties
A complete list of Uloric side effects can be found at WebMD.