Ranbaxy announces USFDA approval of CIP-Isotretinoin NDA

Gurgaon/Princeton (India, USA)  - Ranbaxy Laboratories Inc. (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), today announced that the U.S. Food and Drug Administration (FDA) has approved Absorica, a novel, patented brand formulation of the acne medication isotretinoin, developed by Cipher, for the treatment of severe recalcitrant nodular acne.

Through a business agreement with the Canadian firm, Cipher Pharmaceuticals Inc., RLI is expected to launch Absoricaâ„¢ in the U.S. in Q4 2012; as per the agreement, Ranbaxy will pay royalties on net sales to Cipher.

“We are thrilled to make Absorica available as a valuable option for the dermatologists and patients who need treatment for severe recalcitrant nodular acne. Absorica is a critical milestone in our commitment to serve the dermatology community and will be the flagship brand for Ranbaxy’s specialized dermatology sales force” said Venkat Krishnan, Senior Vice President and Regional Director, Americas, Ranbaxy.

“Approval of Absorica represents our third FDA approval and most important milestone to date, reflecting the great work by our Scientific Affairs team at Cipher and our partner, Galephar Pharmaceutical Research,” said Larry Andrews, President and CEO of Cipher. “We look forward to working closely with our partner, Ranbaxy Laboratories Inc., in preparation for the upcoming U.S. launch of the product through its dermatology sales force.”