FDA Takes Step Toward Allowing ANDAs For Zometa

Law360, New York (April 14, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has determined that Novartis AG’s bone cancer drug Zometa was not withdrawn from sale for reasons of safety or effectiveness, paving the way for generic-drug manufacturers to file abbreviated new drug applications.

The findings, which were published in the Federal Register on Tuesday, will allow the FDA to approve ANDAs for zoledronic acid lyophilized powder for injection, marketed under the name Zometa.

“FDA’s independent evaluation of relevant information has uncovered no information that would indicate this product was withdrawn for...
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