Ranbaxy Laboratories announced the launch of Absorica (isotretinoin) capsules, a product licensed from Cipher Pharmaceuticals. Absorica is indicated for the treatment of severe recalcitrant nodular acne in patients ≥12 years old.
Absorica was approved based on a large double-blind, randomized, parallel-group clinical trial conducted in 925 patients with severe recalcitrant nodular acne to evaluate the efficacy and safety of Absorica compared to a generic product of Accutane (1:1 ratio) under fed conditions. Patients were treated with an initial dose of 0.5mg/kg/day in two divided doses for the first 4 weeks followed by 1mg/kg/day in two divided doses for the following 16 weeks. Results showed patients with at least a 90% reduction in total nodular lesion count from Baseline to Week 20.
Absorica is a retinoid that inhibits sebaceous gland function and keratinization. Unlike isotretinoin, which is highly lipophilic and must be given with a high-fat meal, Absorica is formulated using patented Lidose technology and may be given without regard to meals. The fasting AUC of Absorica is approximately 83% greater than that of Accutane and is therefore not interchangeable or substitutable for generic Accutane products.
Absorica is available in 10mg, 20mg, 30mg, and 40mg capsules in 30-count boxes.
For more information call (609) 720-9200 or visit www.ranbaxy.com.