Navigation Links
Ranbaxy Announces U.S. FDA Approval of CIP-Isotretinoin NDA
Date:5/29/2012

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™, 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™ 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™ is a registered trademark of Cipher PharmaceuticalsCONTACTS:Charles M. CaprarielloRobert FerrisVice President, Corporate CommunicationsRF Binder Partners Inc.Ranbaxy Inc.(212) 994-7505(609) 720-5615

 
'/>"/>

SOURCE Ranbaxy Laboratories Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Department of Justice files consent decree of permanent injunction against Ranbaxy
2. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
3. Marshall Edwards Announces First Cohort Of Patients Dosed In Phase I Clinical Trial Of Oncology Drug Candidate ME-344
4. Depomed Announces Filing Of Shelf Registration To Replace Existing Shelf
5. Mylan Announces Settlement Agreement in Litigation Relating to its Generic Xopenex®
6. Endo Announces Resolution of Patent Litigation with Watson Pharmaceuticals Related to Lidoderm®
7. Horizon Pharma Announces Issuance of U.S. Patent Covering RAYOS (delayed-release prednisone)
8. Watson Announces Lidoderm® Patent Challenge Settlement
9. Agendia Announces Nine Studies in Breast and Colon Cancer for Presentation at 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO)
10. Acacia Pharma Announces Excellent Phase II Results for APD421 in Post-Operative Nausea & Vomiting (PONV)
11. Mylan Announces Settlement Agreement in Patent Infringement Litigation Relating to Sunovions Brovana® Product
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/22/2017)... ANGELES , March 22, 2017  ImaginAb Inc. today announced ... Joseph Limber , chairman of ImaginAb, said ... strong track record that is directly relevant to our business, particularly ... We believe that with his leadership, we can realize our potential." ... Mr. Coombs is ...
(Date:3/22/2017)... 22. März 2017   VWR ... tätige Anbieter von Produkten und Dienstleistungen für ... von EPL Archives Inc. bekannt, eines internationalen ... im kompletten Zyklus regulierter Forschung, Entwicklung und ... Speicherung von Dokumenten und Zusatzdienstleistungen zur Seite ...
(Date:3/22/2017)... Research and Markets has announced the addition of the ... to 2025" report to their offering. ... The Global Pharmaceutical Packaging Market is ... next decade to reach approximately $129.81 billion by 2025. ... the given segments on global as well as regional levels presented ...
Breaking Medicine Technology:
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... Sharon Kleyne, ... Global Climate Change and Your Health on VoiceAmerica, recently talked on her program about ... also used the occasion to remind listeners of an important distinction. World Water Day, ...
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... ... Monthly Monitoring Healthcare products at competitive pricing. Verisys through its ... Exclusions, Debarments, License restrictions and Disciplinary actions. , “We are delighted to be ...
(Date:3/23/2017)... (PRWEB) , ... March 23, ... ... Reports: Complying with European Guidelines and the New MEDDEV 2.7/1 Rev. 4 ... p.m. ET, http://www.fdanews.com/mdclineval                  , How will the new EU MDR ...
(Date:3/23/2017)... ... , ... “Wounded Woman Be Ye Healed-Passing On A Legacy”: a call to ... the creation of published author, Desiree M Webb, a registered nurse, minister of music, ... happily married to her husband, Paul, for over twenty-nine years. Desiree enjoys writing, ...
(Date:3/23/2017)... , ... March 23, 2017 , ... “More Corruption”: a simple and strong explanation ... is one of the rulers of Heaven was asked by God to write a book ... discrimination against me just because I kept my commitment to the Lord God. They have ...
Breaking Medicine News(10 mins):