Treats portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. ANDA 76645, held by Bajaj. Lactulose.
As of Nov 13, 2026, ANDA 76645 (Lactulose), held by Bajaj, was first approved by FDA on Jul 28, 2003, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia level by 25 to 50%; this is generally paralleled by an improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose solution therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lactulose10GM/15ML · solution;oral, rectal | Lactulose | Rx |
| Feb 20, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jul 28, 2003 | Original application | Approved | None posted |
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
