For chronic. ANDA 218640, held by Ascent Pharms Inc. Lubiprostone.
As of Nov 14, 2026, ANDA 218640 (Lubiprostone), held by Ascent Pharms Inc, was first approved by FDA on Jan 2, 2025, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Lubiprostone capsules 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. o 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 2, 2025 | 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
