Shorla wins FDA nod for ready-to-dilute Tepylute
US-Ireland drugmaker Shorla Oncology has received approval from the US regulator for a new multi-dose vial of Tepylute (thiotepa), a chemotherapy treatment for breast and ovarian cancers.
The formulation, designed to improve dosing efficiency and reduce preparation errors, is the first ready-to-dilute version of the drug, removing the need for reconstitution.
The company said the 100mg vial offers more flexibility for providers and patients. “Once opened, our 100mg vial of Tepylute is stable for 14 days when properly stored,” said chief executive Sharon Cunningham, noting the benefit for clinical scheduling.
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