HAWTHORNE, N.Y., Mar 8, 2004 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. (NASDAQ: TARO) reported today that its U.S. affiliate has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Phenytoin Oral Suspension USP, 125 mg / 5mL ("phenytoin oral suspension").

Taro's phenytoin oral suspension is bioequivalent to Parke-Davis' (a division of Warner Lambert) Dilantin-125(R). Phenytoin oral suspension is an antiepileptic prescription product used in controlling grand mal and temporal lobe seizures and is approved for pediatric use. According to industry sources, U.S. sales of phenytoin oral suspension products were approximately $23 million in 2003.

"Phenytoin oral suspension is an important product for treating epilepsy in children, an area in which Taro provides several products," said Barrie Levitt, M.D., Chairman of the Company.

Joins Taro's Line of Central Nervous System Products

In the U.S., Taro markets carbamazepine chewable tablets and oral suspension, used primarily in pediatrics. Like phenytoin oral suspension, these prescription anticonvulsant products are indicated for the control of seizure disorders.

Currently, Taro has 34 filings at the FDA: 33 ANDAs, including tentative approvals for fluconazole tablets and loratadine syrup, plus a New Drug Application related to the Company's proprietary NonSpil(TM) liquid drug delivery system. In addition, the Company has regulatory filings in Canada, Israel and other countries around the world.

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.

Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the introduction of the Company's phenytoin oral solution product and other Taro central nervous system products. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro's phenytoin oral solution product and other central nervous system products; changes in the Company's financial position; regulatory actions; and, other risks detailed from time to time in the Company's SEC reports, including its 2002 Annual Report on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.

SOURCE: Taro Pharmaceutical Industries Ltd.

Taro Pharmaceutical Industries Ltd.
Daniel Saks, 914-345-9000 ext. 6208
or
Kevin Connelly, 914-345-9000 ext. 6338

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