Lactulose oral solution

Form: Oral solution

Strength: 10 g/15 mL

Reference Brands: Enulose(US)

Category: Gastrointestinal Drugs

Lactulose oral solution, marketed as Duphalac and Enulose, is approved in the US by the FDA and in the EU via EMA for constipation and hepatic encephalopathy. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data, while EMA ensures compliance with regional safety and manufacturing requirements. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports timely approval, safe use, and worldwide availability of lactulose oral solutions, enhancing gastrointestinal and liver health management across diverse patient populations globally.