For alcohol dependence. ANDA 218984, held by Somerset Theraps LLC. Acamprosate Calcium.
As of Nov 15, 2026, ANDA 218984 (Acamprosate Calcium), held by Somerset Theraps LLC, was first approved by FDA on Mar 16, 2026, with 0 approved supplements and 0 published complete response letters.
Acamprosate calcium is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium treatment. The efficacy of acamprosate calcium in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 16, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acamprosate Calcium333MG · tablet, delayed release;oral | Acamprosate Calcium | 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
