Treats portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. ANDA 90502, held by Fresenius Kabi. Lactulose.
As of Nov 13, 2026, ANDA 90502 (Lactulose), held by Fresenius Kabi, was first approved by FDA on Jan 25, 2012, with 0 approved supplements 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 levels 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 therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lactulose10GM/15ML · solution;oral, rectal | Lactulose | 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
