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# Shorla NDA Accepted for Breast/Ovarian Cancer
- URL: https://www.fdaweb.com/shorla-nda-accepted-for-breast-ovarian-cancer/
- Published: 2024-01-11T12:00:00.000Z
- Updated: 2026-09-14T14:20:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156128

FDA has accepted for review a Shorla Oncology NDA for SH-105 for treating breast and ovarian cancer. The agency has set a user fee review action target date of 6/29.

SH-105 is described as a ready-to-dilute form of a well-established undisclosed 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,” the company says. “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.”

Shorla says that more than 350,000 women will be diagnosed with breast cancer in the U.S in 2023, and about 20,000 women will be diagnosed with ovarian cancer.