Phentermine/Topiramate Extended-Release Capsules

Form: Capsules

Strength: 3.75 mg/23 mg, 7.5 mg/46 mg, and 15 mg/92 mg

Reference Brands: Qsymia(US & EU)

Category: Weight Loss drugs

Phentermine/Topiramate extended-release capsules, marketed as Qsymia, are approved in the US by the FDA and in the EU via EMA for weight management in obese adults. Regulatory approval requires dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For dossier preparation, regulatory pathways, and market access guidance, visit PharmaTradz. Proper adherence to regional regulations supports swift approval, safe administration, and worldwide availability, helping patients achieve effective weight loss and health improvements through high-quality extended-release capsules supported by regional authorities.