Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns

NDA and BLA Calendar Year Approvals

FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.

Innovative drugs often mean new treatment options for patients and advances in health care for the American public.

It has become increasingly clear that new approach methodologies (NAMs)—when combined with knowledge of the pathway, results of pharmacology studies, and other relevant data—may offer ways to reduce animal testing.

Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product