PRINCETON, N.J., June 2 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Doxycycline Tablets 50mg, 75mg and 100mg in the U.S. market. The FDA’s Office of Generic Drugs has determined the Ranbaxy formulation to be bioequivalent and have the same therapeutic effect as that of the branded drug Adoxa(R), marketed by Bioglan Pharmaceutical Co. Annualized market sales for Adoxa(R) were $ 57.2 million of Doxycycline market which achieved sales of $62.7 million (IMS - MAT: March 2006).
Doxycycline is indicated for a variety of infections when caused by susceptible strains of microorganisms including: respiratory tract and urinary tract infections, skin and skin structure infections, and severe acne as adjunctive therapy.
“Ranbaxy is pleased to receive this most recent approval from the U.S. FDA. Doxycycline will add to our ever-expanding product portfolio of affordable generic alternatives that will have a positive effect on the economics of healthcare. Doxycycline 50mg, 75mg and 100mg will be made available under the Ranbaxy label through wholesalers, distributors and pharmacies on a nationwide basis as supply of product reaches levels to support market demand,” (according) said (to) Jim Meehan, VP of Sales and Marketing for RPI.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India’s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
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 49 countries and manufacturing operations in 7 countries.
* Adoxa(R) is a registered trademark Par Pharmaceutical, Inc. CONTACTS: Charles M. Caprariello Vice President, Corporate Communications Ranbaxy Inc. (609) 720-5615 Edwige Buteau RF Binder Partners Inc. (212) 994-7517 Anuj Baveja RF Binder Partners Inc. (212) 994-7552
Ranbaxy Laboratories Limited
CONTACT: Charles M. Caprariello, Vice President, Corporate Communications,Ranbaxy Inc., +1-609-720-5615; Edwige Buteau, +1-212-994-7517, or AnujBaveja, +1-212-994-7552, both of RF Binder Partners Inc.
Web site: http://www.ranbaxy.com/