Ranbaxy Laboratories Inc., a wholly-owned subsidiary of Ranbaxy Laboratories has announced the sales and promotion launch of Absorica (Isotretinoin) capsules, a product that is licensed from Mississauga, Ontario-based Cipher Pharmaceuticals Inc.
Absorica is indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older.
Ashish Anvekar, senior director, Ranbaxy Laboratories Inc. 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."
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 AUCo-t of Absorica is around 83 percent greater than that of Accutane, while both products are bio-equivalent 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, the company said.