Lomustine Capsules are an alkylating drug indicated for the treatment of patients with: Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. Hodgkin’s lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. 1.1 Brain Tumors Lomustine Capsules are indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2025 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
