Zurich: US 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.
Bureau Report