ROCKLAND, Mass. — The Food and Drug Administration has extended its review period for a multiple sclerosis drug made by EMD Serono, the drug maker said Friday.
EMD Serono — the U.S. subsidiary of German drug maker Merck KGaA, which uses the name to avoid confusion with U.S.-based Merck — said the FDA had extended the review time for cladribine tablets to Feb. 28. The drug is a disease-modifying drug for relapsing MS.
The FDA gave the drug an expedited review period in July, reducing the standard 10-month review period to six months. EMD said the FDA extended the review period to give it more time for a full review of additional information included in the regulatory application.