Healthcare Industry News:  Valtrex 

Biopharmaceuticals Generics FDA

 News Release - February 1, 2007

Ranbaxy Receives Final FDA Approval to Manufacture and Market Valacyclovir HCl Tablets

PRINCETON, N.J., Feb. 1 (HSMN NewsFeed) -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration to market Valacyclovir Hydrochloride tablets, 500 mg (base) and 1 g (base). The Division of Bioequivalence has determined the Ranbaxy formulation to be bioequivalent and, therefore, therapeutically equivalent to Valtrex Caplets, 500mg (base) and 1 g (base) respectively of GlaxoSmithKline. Valacyclovir HCl has combined sales totaling $1.26 billion (IMS - MAT: September 2006).

Valacyclovir HCl is indicated for the treatment of herpes zoster (shingles) and also for the treatment or suppression of genital herpes in immunocompetent individuals and for the suppression of recurrent genital herpes in HIV-infected individuals. Valacyclovir HCl is also indicated for the treatment of cold sores (herpes labialis).

"Valacyclovir is a product that will further expand our ever-growing portfolio of affordable generic alternatives in the anti-infective arena, and we are pleased to receive final approval from the U.S. FDA. We anticipate that our generic formulation of Valacyclovir hydrochloride tablets will provide benefits to the U.S. healthcare system, including both prescribers and patients," said 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, 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 9 countries.

* Valtrex is a registered trademark of GlaxoSmithKline



Source: Ranbaxy Pharmaceuticals

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