26 Nov 2012, BioSpectrum Bureau , BioSpectrum
New Delhi: Indian pharmaceutical company Ranbaxy Laboratories is launching Absorica (Isotretinoin) capsules, a product licensed from Cipher Pharmaceuticals of Mississauga, Ontario, in the US. Absorica is indicated for the treatment of severe recalcitrant nodular acne in patients of 12 years of age and older.
Due to its high lipophilicity, oral absorption of isotretinoin is enhanced when given with a high-fat meal. However, Absorica, which is formulated using patented Lidose technology, can be given without regards to meals. The fasted AUC0-t of Absorica is approximately 83 percent greater than that of Accutane, while both products are bioequivalent under fed conditions. Absorica is, therefore, not interchangeable and not substitutable with generic products of Accutane. Absorica, NDA, was approved based on a large pivotal clinical trial enrolling 925 patients.
Dr Ashish Anvekar, senior director, Ranbaxy Laboratories, said, "We are most pleased to make Absorica available as a valuable option for dermatologists and a subset of patients who suffer from severe recalcitrant nodular acne. Absorica will be the flagship brand of the Ranbaxy dermatology product portfolio in the US."