For chronic. ANDA 209920, held by Teva Pharms USA Inc. Lubiprostone.
As of Nov 14, 2026, ANDA 209920 (Lubiprostone), held by Teva Pharms USA Inc, was first approved by FDA on Jan 18, 2022, with 0 approved supplements 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 |
|---|---|---|---|
| Jan 18, 2022 | Original application | Approved |
| 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
