Merck KGaA Says FDA Extends Review for Cladribine
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U.S. regulators extended the review period for Merck KGaA’s cladribine multiple sclerosis pill by three months, a setback for the drugmaker in the race with Swiss rival Novartis AG.
The Food and Drug Administration extended the pill’s priority review period by three months to Feb. 28, 2011, to examine additional information on the product, Darmstadt, Germany-based Merck said in an e-mailed statement today.