Ranbaxy Laboratories Limited has received approval from the US Food and Drug Administration to manufacture and commercialize Isotretinoin Capsules USP, 30 mg, representing a new dosage strength for Isotretinoin. Ranbaxy ' s wholly owned subsidiary, Ranbaxy Pharmaceuticals Inc. (RPI) will market this product under the brand name Sotret that will provide dosing flexibility to physicians and complement the existing strengths (10, 20, and 40 mg) currently available in the market that are commercialized under the Ranbaxy label.

Isotretinoin (Accutane) Capsules are indicated for severe recalcitrant nodular acne. However, because of adverse effects associated with its use, Isotretinoin is reserved for patients with severe nodule acne that are unresponsive to conventional therapy, including systemic antibiotics. Overall sales of Accutane totaled $415 million (IMS - MAT: March 2003).

Sotret is being promoted by the Ranbaxy Brand Products Division (B.P.D.), towards building a portfolio of products with brand names. B.P.D. has established a team of over 35 Professional Sales Representatives who promote Sotret to prescribers of Isotretinoin. The Product will be placed in all distribution channels and be available in wholesalers and pharmacies throughout the U.S. as product becomes available.

According to Dipak Chattaraj, President of RPI, “With this new 30 mg strength, dosing titration can be more effectively tailored to meet patient needs and represents our contribution to adding clinical utility to this product. We believe this will benefit prescribers, patients and health plans in allowing the optimal dose to be provided through flexibility of dosing, and that physicians will find this strength as adding clinical value to this molecule.”