Treats portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. ANDA 74603, held by Chartwell Rx. Lactulose.
As of Nov 13, 2026, ANDA 74603 (Generlac), held by Chartwell Rx, was first approved by FDA on Oct 31, 1996, with 5 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 solution therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 1996 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Generlac10GM/15ML · solution;oral, rectal | Lactulose | Rx |
| Nov 26, 2001 | Supplement 5Labeling | Approved | None posted |
| Apr 5, 2001 | Supplement 4Labeling | Approved | None posted |
| Apr 14, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Apr 14, 2000 | Supplement 2Manufacturing | Approved | None posted |
| Jul 15, 1999 | Supplement 3Labeling | Approved | None posted |
| Oct 31, 1996 | 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
