For Graves’ disease with hyperthyroidism or toxic multinodular goiter. ANDA 218149, held by Bionpharma. Methimazole.
As of Nov 13, 2026, ANDA 218149 (Methimazole), held by Bionpharma, was first approved by FDA on Sep 25, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Methimazole tablets are indicated: In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option. To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 25, 2023 | Original application | Approved | None posted |
| Methimazole5MG · tablet;oral | Methimazole | Rx |
| Methimazole10MG · tablet;oral | Methimazole | Rx |
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
