In a setback for Novartis AG, the U.S. Food and Drug Administration asked the Swiss drug maker for more information about its meningitis-vaccine candidate, Menveo, with respect to patients between ages 11 and 55. "The FDA has requested additional information mainly on the manufacturing of the drug, but it didn't ask about data on the safety or efficacy of Menveo," Novartis spokesman Eric Althoff said. Novartis now expects the drug to be approved late in 2009 or early in 2010, he said. Novartis had expected to get approval for the drug this year. "While the financial impact is small, the setback is nevertheless a disappointment," said Vontobel analyst Andrew Weiss Menveo has shown, in extensive clinical trials, that it can protect against the four most common subgroups of meningitis. It is seen as an important driver of No-vartis's future sales, with analysts estimating a peak annual sales potential of about $650 million. New trials won't be necessary and Novartis expects to "fully respond" to the FDA's questions by the end of 2009, the company said. Earlier this year, Novartis said approval for Menveo as a treatment for younger children will also be delayed in the U.S., because the FDA asked to test the drug on 1,500 more children.