PRINCETON, N.J., June 22 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Terbinafine Hydrochloride Tablets, 250 mg. Total annual market sales for Terbinafine Hydrochloride Tablets, 250 mg were $678.5 million (+16%) of which tablets accounted for 96% of Terbinafine sales totaling $706 million (IMS - MAT: March 2005).
Lamisil(R) (Terbinafine Hydrochloride) Tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
"We are pleased to receive this tentative approval for Terbinafine Hydrochloride Tablets. This product represents a future opportunity for Ranbaxy and will be launched following final approval from the FDA," according to Jim Meehan, Vice President 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, India's largest pharmaceutical company, manufactures and markets brand and generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 44 countries and manufacturing operations in 7 countries.
*Lamisil(R) is a registered trademark of Novartis Pharmaceutical Corporation
Ranbaxy Pharmaceuticals Inc.
CONTACT: Charles M. Caprariello, Vice President, Corporate Communicationsof Ranbaxy Inc., +1-609-720-5615; or Edwige Buteau, +1-212-994-7517, orAnuj Baveja, +1-212-994-7552, both of RF Binder Partners Inc.