FDA accepts NDA for SH 201 the first palatable oral liquid of the related chemotherapeutic agent, for the treatment of certain forms of leukemia and other cancers
The FDA has accepted the new drug application (NDA) for SH 201, the first palatable oral liquid of the related chemotherapeutic agent, for the treatment of certain forms of leukemia and other cancers
The regulatory body assigned a Prescription Drug User Fee Act action date of November 30, 2024.
“With this NDA acceptance for SH 201, we are a step closer to providing an alternative treatment to thousands of United States patients diagnosed with leukemia and other cancers who do not currently have the option of an oral liquid,” Sharon Cunningham, chief executive officer and co-founder of Shorla Oncology, stated in the press release. “Submitting this drug to the FDA for review is more than just a milestone for our company, it’s an important moment for all those impacted by this disease including patients, caregivers and clinicians.”
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