For chronic. ANDA 209450, held by Amneal. Lubiprostone.
As of Nov 14, 2026, ANDA 209450 (Lubiprostone), held by Amneal, was first approved by FDA on Nov 30, 2021, with 1 approved supplement and 0 published complete response letters.
Lubiprostone capsules are a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Limitations of Use: Effectiveness of lubiprostone capsules in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. (1.2, 7.1) irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 30, 2021 | Original application | Approved |
| Lubiprostone8MCG · capsule;oral | Lubiprostone | Rx |
| Lubiprostone24MCG · capsule;oral | Lubiprostone | Rx |
| May 5, 2022 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 30, 2021 | Original application | Approved |
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
