FDA ISSUES SECOND APPROVABLE LETTER FOR TAP'S GOUT DRUG

The FDA issued a second approvable letter for a treatment for gout, febuxostat, developed by TAP Pharmaceutical Products, a joint venture of Abbott Laboratories and Takeda Pharmaceutical.

Approvable letters typically indicate the FDA might approve a drug, but only after receiving additional information. Abbott didn't disclose the reasons for the approvable letter, the second such letter for the drug in less than a year.

TAP filed for FDA approval of febuxostat in December 2004. In October 2005, the FDA issued its first approvable letter for the drug. At that time, TAP said it was confident it would be able to address the contents of the letter and get final approval, and it expected to launch the drug this year.

In studies, the oral drug has been shown to lower levels uric acid. Elevated uric acid levels are associated with gout, an inflammatory arthritis. The most common side effects in studies were liver function test abnormalities, diarrhea, headache and nausea, but TAP said adverse events were mild to moderate.