Ivax Corporation has received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for gabapentin capsules in 100 mg, 300 mg and 400 mg strengths. Upon final approval this product will be sold through the company's wholly owned subsidiary, Ivax Pharmaceuticals, Inc. Gabapentin is the generic equivalent of Neurontin, which is used to treat epileptic seizures and is marketed by Warner-Lambert, a unit of Pfizer, Inc. Neurontin had US sales of over $2.2 billion during the twelve months ending in June 2003.
Warner-Lambert sells Neurontin in 5 dosage strengths, 100 mg, 300 mg and 400 mg capsules and 600 mg and 800 mg tablets. Ivax has also filed an ANDA for gabapentin tablets in 100 mg, 300 mg, 400 mg, 600 mg and 800 mg dosage strengths and believes that it has first to file status on gabapentin tablets in 100 mg, 300 mg and 400 mg strengths
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 US and internationally.