Ranbaxy Receives Tentative Approval for Gabapentin (Neurontin) Tablets

December 13, 2004

Ranbaxy Receives Tentative Approval for Gabapentin Tablets

13 Dec 2004

Ranbaxy Laboratories Limited (RLL) announced today that the Company has received

tentative approval from the U.S. Food and Drug Administration, Office of Generic

Drugs, to manufacture and market Gabapentin Tablets, 600 and 800 mg strengths.

Earlier in August 2004, RLL had received tentative approval from the U.S. FDA to

manufacture and market Gabapentin Capsules, 100, 300 and 400 mg strengths. Total

sales for Gabapentin were $2.8 billion with Gabapentin Tablets, 600 and 800 mg

strengths, totaling $1.1 billion (+44%) - (IMS - MAT: September 2004).

Gabapentin (Neurontin®) is indicated for the management of postherpetic

neuralgia in adults. Gabapentin is indicated as adjunctive therapy in the

treatment of partial seizures with and without secondary generalization in

patients over 12 years of age with epilepsy and is also indicated as adjunctive

therapy in the treatment of partial seizures in pediatric patients age 3 - 12

years.

According to Jim Meehan, Vice President of Sales and Marketing for RPI, USA, “We

are pleased to receive this tentative approval for Gabapentin Tablets. This

product represents a future opportunity, and we will launch Gabapentin Tablets

following final approval from the FDA.”

Ranbaxy Pharmaceuticals Inc. (RPI) based in ville, Florida, USA, is the

wholly owned subsidiary of 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 34 countries and manufacturing operations in 7

countries.

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