FDA filing acceptance of NDA for novel formulation of SH 105 to treat breast cancer and ovarian cancer
Shorla Oncology announced that the FDA has accepted for review the company’s New Drug Application (NDA) for a novel formulation to treat breast and ovarian cancer. The Agency assigned a Prescription Drug User Fee Act (“PDUFA”) action date of June 29th, 2024
“This innovative drug (SH 105) will offer hospital pharmacists and patients access to a differentiated, ready to administer, injectable product with unique characteristics that’s expected to facilitate rapid adoption once approved” said Orlaith Ryan, Chief Technical Officer and Co-Founder of Shorla Oncology.”
SH-105 is a ready-to-dilute form of a well-established drug that has been used as a freeze-dried powder since the 1950s and has seen supply shortages SH 105’s liquid form eliminates the need for powder to be reconstituted, improving efficiency, and reducing the risks associated with the complexity of preparation.
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