Neurontin (Gabapentin) News

[Guest guest]

IVAX Receives Final Approval and First to File Status on Gabapentin

Tablets

MIAMI--(BUSINESS WIRE)--April 28, 2004--IVAX Corporation (AMEX:IVX)

(LSE:IVX.L) received final approval and confirmation of its

first-to-file status from the United States Food and Drug Administration

(FDA) for its Abbreviated New Drug Application (ANDA) for gabapentin

tablets in 100 mg, 300 mg and 400 mg dosage strengths, for which IVAX

will have 180-day exclusivity. Gabapentin is the active ingredient in

Neurontin®, which is used to treat epileptic seizures and is marketed

by Warner-Lambert, a unit of Pfizer Inc. Neurontin had U.S. sales of

approximately $2.4 billion in 2003.

Neurontin is sold by Warner-Lambert in 5 dosage strengths, 100 mg, 300

mg and 400 mg capsules and 600 mg and 800 mg tablets. Tablets in the 100

mg, 300 mg and 400 mg dosage strengths are not currently marketed and

IVAX intends to market them through its wholly owned subsidiary, IVAX

Pharmaceuticals, Inc. IVAX is able to launch these tablets at any time

and is considering a variety of factors in determining when to launch.

IVAX has also just received tentative approval from the FDA for its ANDA

for gabapentin tablets in 600 mg and 800 mg dosage strengths, currently

marketed by Warner-Lambert, and had previously received a tentative

approval from the FDA on its ANDA for the 100 mg, 300 mg, and 400 mg

capsules, currently marketed by Warner-Lambert. IVAX is presently

litigating whether its gabapentin products infringe a patent held by

Pfizer. A trial in the U.S. District Court of New Jersey has not yet

been scheduled.

IVAX continues its aggressive program to increase the number of products

in its generic portfolio.

IVAX Corporation, headquartered in Miami, Florida, discovers, develops,

manufactures, and markets branded and brand equivalent (generic)

pharmaceuticals and veterinary products in the U.S. and internationally.