IVAX Corporation (IVX) Receives Final Approval On 600 And 800 Mg Gabapentin Tablets
10/19/2005 5:10:41 PM
MIAMI--(BUSINESS WIRE)--May 2, 2005--IVAX Corporation (AMEX:IVX) (LSE:IVX.L) (WSE:IVX) announced today that it received final approval on April 29, 2005 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for gabapentin 600 and 800 mg tablets. Upon FDA approval, IVAX' wholly owned subsidiary, IVAX Pharmaceuticals, Inc., launched this product. Gabapentin is the generic equivalent of Neurontin(R) which is marketed by Warner-Lambert, a unit of Pfizer, Inc. to treat seizures and postherpetic neuralgia (PHN). According to IMS data, U.S. sales for gabapentin 600 and 800 mg tablets and Neurontin 600 and 800 mg Tablets in 2004 were $1.1 billion.
In February, 2005, IVAX entered into a settlement of litigation with the FDA and Alpharma, Inc. regarding gabapentin. Pursuant to the settlement, Alpharma waived its FDA awarded 180-day exclusivity in favor of IVAX, effective on March 23, 2005 for gabapentin 100, 300 and 400 mg capsules and April 29, 2005 for gabapentin 600 and 800 mg tablets. IVAX launched its gabapentin 100, 300 and 400 mg capsules on March 23, 2005.
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