For chronic. ANDA 214131, held by Zydus Pharms. Lubiprostone.
As of Nov 14, 2026, ANDA 214131 (Lubiprostone), held by Zydus Pharms, was first approved by FDA on Mar 23, 2023, with 0 approved supplements and 0 published complete response letters.
Lubiprostone is 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 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 |
|---|---|---|---|
| Mar 23, 2023 | Original application | Approved | None posted |
| Lubiprostone8MCG · capsule;oral | Lubiprostone | Rx |
| Lubiprostone24MCG · capsule;oral | Lubiprostone | 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
