Abbott Laboratories has revealed that the FDA has once again delayed any release of its experimental gout therapy, which it is developing with Japan's Takeda Pharmaceuticals. The news came in an FDA approvable letter for febuxostat. It was the second approvable letter their joint venture, TAP Pharmaceuticals, has received in less than a year. TAP declined to specify any of the remaining issues that the FDA outlined in the letter, saying it was confidential. TAP filed for approval in late 2004 and later announced in '05 that it was confident that researchers could address the agency's concerns outlined in the FDA's first approvable letter.
- here's the report on TAP from MarketWatch