Shares of Pfizer (ticker: PFE) were down 3.4% in premarket trading on Monday. Opko (OPK) stock dropped 11.3%. On Friday, the U.S. Food and Drug Administration issued a Complete Response Letter for the Biologics License Application.

Last week, Japan’s Ministry of Health approved the drug, which will be sold under the brand name Ngenla. The drug is expected to be available in the U.S. in the next few months. It is not yet known if the drug will be available to the public in Japan.
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