FDA approves Tepylute
Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, announced that the FDA has granted approval for 100 mg/10mL multi-dose vial of Tepylute, a ready-to-dilute formulation of thiotepa to treat breast and ovarian cancer, that eliminates the need for reconstitution and may reduce preparation time and errors offering more scheduling flexibility for their patients.
Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, announced that the FDA has granted approval for 100 mg/10mL multi-dose vial of Tepylute, a ready-to-dilute formulation of thiotepa to treat breast and ovarian cancer, that eliminates the need for reconstitution and may reduce preparation time and errors offering more scheduling flexibility for their patients.
“We are pleased to offer another viable treatment option for patients with breast and ovarian cancer,” said Sharon Cunningham, Chief Executive Officer and Co-Founder of Shorla Oncology. “Once opened, our 100mg vial of Tepylute is stable for 14 days when properly stored, giving providers the flexibility they need when preparing and administering this very important treatment.
Tepylute is a ready to dilute formulation of a well-established, standard of care oncology drug thiotepa that has been manufactured as freeze-dried powder since the 1950s.
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