Taro Receives FDA Approval For Ondansetron Hydrochloride Injection USP, 2 Mg/mL ANDA

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 28 Mar 2008 - 1:00 PST

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Taro Pharmaceutical Industries Ltd. ("Taro," the "Company," Pink Sheets: TAROF) reported that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Ondansetron Hydrochloride Injection USP, 2 mg/mL ("Ondansetron Injection").

Taro's Ondansetron Injection is used for the prevention of nausea and vomiting associated with chemotherapy. This new Taro sterile injectable prescription product is bioequivalent to GlaxoSmithKline's Zofran® Injection, 2 mg/mL. Taro's Ondansetron Injection will be manufactured in the Company's sterile facility in Ireland. According to industry sources, branded and generic injectable ondansetron products had U.S. sales of more than $150 million in 2007.

Taro Pharmaceutical Industries Ltd. 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 http://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 Company's ondansetron hydrochloride injection product. These statements include, but are not limited to, statements that do not describe historical facts and statements that refer or relate to events or circumstances the Company "plans", "believes", or "expects" to happen, "may" happen, or similar language. 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; marketplace acceptance of the new Taro ondansetron hydrochloride injection product; 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 Annual Reports 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.

http://www.taro.com