Britain's Shire Pharmaceuticals Group Plc said it had received a letter from US regulators indicating they intend to approve its most important new drug, Fosrenol, for severe kidney disease.
Britain's third-biggest drugmaker said the US Food and Drug Administration had asked for additional data and analysis on Fosrenol, but that it still expected to launch the drug before the end of 2003.
Chief Executive Rolf Stahel said the company expected to satisfy the FDA without the need for new clinical studies.
"It is most likely that we can answer all the questions from existing studies and existing data," he said.
Industry analysts said they believed the FDA wanted more reassurance on the safety profile of Fosrenol. Stahel declined to detail the outstanding issues with the FDA but noted more information on the product would be forthcoming from substantial ongoing clinical trials.
Shire is looking to Fosrenol to help reduce its dependence on its Adderall hyperactivity treatments, which accounted for over a third of sales in 2002 and are facing stiff competition in the market place and threats from generic drugmakers.