TEPYLUTE

June 28, 2024

FDA Approves Tepylute (thiotepa) Ready-to-Dilute Injectable Formulation to Treat Breast Cancer and Ovarian Cancer

Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, announced that the U.S.
Food and Drug Administration (FDA) approved the company’s New Drug Application for Tepylute.

  • Tepylute is a liquid form of a well-established, standard of care oncology drug, thiotepa. The new
    formulation eliminates the need for complex and time-consuming reconstitution, which can reduce
    the risk of drug preparation errors.
  • Tepylute is a ready-to-dilute formulation to treat breast and ovarian cancer in an easier-to-prepare,
    injectable product that also enables dosing accuracy.

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