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OCTOBER 25, 2018

Several More Specialty Meds Expecting Approval This Year

By Marie Rosenthal
Orlando, Fla.—Last year the FDA approved a record 36 specialty medications. This year, the agency has approved 32 with eleven more due for approval by the end of the year, making a new record, according to Aimee Tharaldson, PharmD, Senior clinical consultant, emerging therapeutics, Express Scripts.

New specialty drugs with Prescription Due User Fee Act (PDUFA) dates this year are lorlatinib (Pfizer), loratrectinib (Bayer/Lexo), gilterintinib (Astellas), calaspargase pegol