Ranbaxy Announces U.S. FDA Approval of CIP-Isotretinoin NDA
PRINCETON, N.J., May 29, 2012 /PRNewswire/ — Ranbaxy Laboratories Inc. (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), today announced today that the U.S. Food and Drug Administration (FDA) has approved Absorica(TM), a novel, patented brand formulation of the acne medication isotretinoin, for the treatment of severe recalcitrant nodular acne. Through a business agreement with the Canadian firm, Cipher Pharmaceuticals Inc., RLI is expected to launch Absorica(TM) 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 dermatologist 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.”
About Ranbaxy Laboratories Inc.
Ranbaxy Laboratories Inc. (RLI) is a U.S. based, wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL). RLI is focused on the promotion of branded prescription products in the U.S. RLI has been expanding and growing on the strength of Ranbaxy’s R&D efforts, and continuing exploration of novel drug delivery systems (NDDS), licensing activities, mergers and acquisitions. RLI is expanding the visibility and presence of the Ranbaxy name by bringing value-added brand products to the market.
For more information, please visit www.ranbaxyusa.com.
About Ranbaxy Laboratories Limited
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.
Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary “platform technologies,” resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 46 countries and manufacturing operations in 7 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Daiichi Sankyo is a leading global pharma innovator, headquartered in Tokyo, Japan.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: DND; OTC: CPHMF.PK) is a growing specialty pharmaceutical company that commercializes novel formulations of successful, currently marketed molecules. Cipher’s strategy is to in-license clearly differentiated products, advance them through the clinical development and regulatory approval stages, and out-license to international marketing partners.
* Absorica(TM) is a registered trademark of Cipher Pharmaceuticals
CONTACTS: Charles M. Caprariello Robert Ferris Vice President, Corporate Communications RF Binder Partners Inc. Ranbaxy Inc. (212) 994-7505 (609) 720-5615
SOURCE Ranbaxy Laboratories Inc.