The US Food and Drug Administration (FDA) has approved speciality pharmaceutical company Shorla Oncology’s new drug application (NDA) for TEPYLUTE, a new formulation to treat breast and ovarian cancer. TEPYLUTE is the third drug in the company’s portfolio to obtain FDA approval, with several other cancer drugs awaiting approval for the US market. The gold standard of business intelligence.
Previously known as SH-105, the asset is a ready-to-dilute, injectable product that simplifies preparation and ensures dosing accuracy for breast and ovarian cancer treatments. This new liquid formulation of thiotepa, a standard oncology product, removes the requirement for complex reconstitution and supports “just in time” preparation, enhancing consistency in dosing. Shorla Oncology chief commercial officer Rayna Herman stated: “Among TEPYLUTE’s many benefits, it removes the necessity to reconstitute which can introduce additional risks of drug preparation errors.
“We look forward to providing an update on our launch plans for TEPYLUTE in the near future.” Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
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