Corcept Therapeutics · thư phản hồi hoàn chỉnh đã sửa (NDA 219398)

Trích đoạn nguồn

¢ IN U.S. FOOD & DRUG ADMINISTRATION NDA 219398 THƯ PHẢN HỒI HOÀN CHỈNH ĐÃ SỬA Corcept Therapeutics Attention: Christopher Golis Vice President, Quality Assurance & Regulatory Affairs 101 Redwood Shores Parkway Redwood City, CA 94065 Dear Christopher Golis: Please refer to your new drug application (NDA) dated and received , and your amendments, submitted under for relacorilant capsules. We also refer to our complete response letter dated December 30, 2025, which contained no errors but is being updated to respond to Concept's communication dated This corrected action letter incorporates revisions for clarity. The effective action date will remain December 30, 2025, the date of the original letter. We have completed our review of this application, as amended, and have determined

openFDA