* FDA poses additional questions before further review
* Drug already approved for use in two to 55-year-olds
ZURICH Feb 13 U.S. authorities have asked
Novartis for more information on its meningitis vaccine
Menveo, holding up the company's application to extend the use
of the drug to American toddlers and infants, the Swiss
drugmaker said on Monday.
Menveo protects against strains of the meningococcal
disease, a cause of potentially deadly meningitis, and is
already approved in the United States for people aged between
two and 55.
The FDA's Complete Response letter said the regulatory body
has completed its review of Novartis's application to extend the
use of the drug, which the company submitted in April, and said
it wanted answers to more questions before a further review.
Novartis, the maker of high blood pressure drug Diovan, had
already failed to gain Food and Drug Administration approval for
the use of the drug to treat infants and toddlers up to two
years of age last year.