HAWTHORNE, N.Y., Nov. 17, 2003 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. (Nasdaq:TARO) reported today that its U.S. affiliate has filed an Abbreviated New Drug Application ("ANDA") with the U.S. Food and Drug Administration ("FDA") for gabapentin capsules in 100 mg, 300 mg and 400 mg strengths.
The products are intended to be marketed as generic equivalents of Pfizer's Neurontin(r) capsules in the same strengths. Gabapentin capsules are used in treating epilepsy and post-herpetic neuralgia.
Taro submitted its ANDA to the FDA with a Hatch-Waxman Act "Paragraph IV" certification. As expected, Pfizer has filed a patent infringement lawsuit against Taro to prevent the FDA approval of Taro's ANDA for these gabapentin products. Other companies have filed ANDAs for these products and are engaged in similar lawsuits with Pfizer. Taro intends to defend its position vigorously. According to industry sources, U.S. sales of Neurontin capsules were approximately $1.4 billion in 2002.
Taro is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at www.taro.com.