www.taro.com

Trademarks and Copyright© The images and information contained in the Site are, to the fullest extent possible, copyrighted and otherwise proprietary. It is the policy of Taro to enforce its intellectual property rights to the fullest extent of the law, including (where applicable) seeking criminal sanctions.

News Release

<< Back



Taro Receives Approval for Children's ElixSure IB -Ibuprofen- Oral Suspension NDA

    HAWTHORNE, N.Y.--(BUSINESS WIRE)--Jan. 8, 2004--

     OTC Formulation Extends Line of Spill-Resistant ElixSure(TM)
                          Pediatric Products

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 New Drug Application ("NDA") for Children's ElixSure(TM) IB (ibuprofen) Oral Suspension, 100mg/5mL. The spill-resistant product utilizes the proprietary NonSpil(TM) liquid drug delivery system developed by Taro researchers.

ElixSure(TM) IB will be sold over-the-counter ("OTC") for reducing fever and relieving pain in children. ElixSure(TM) IB will extend Taro's ElixSure(TM) line of OTC liquid medicines for children. The spill-resistant formulation provides parents with greater ease and accuracy of dosing. The other single-symptom Children's ElixSure(TM) formulations are for fever/pain (acetaminophen), cough (dextromethorphan HBr) and congestion (pseudoephedrine HCl).

ElixSure(TM) IB comes in a good-tasting berry flavor and provides six to eight hours of relief. In addition to its spill-resistant properties, ElixSure(TM) IB is different from other ibuprofen suspensions. The product does not require shaking prior to administration. Other ibuprofen suspensions tend to settle and require shaking prior to use. Together, ElixSure(TM) IB and the ElixSure(TM) acetaminophen product enable parents to choose between the two most popular OTC options in treating children with fever or pain.

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. These statements include, but are not limited to, statements that are not describing historical facts, and comments concerning the potential benefits of ElixSure(TM) products, and the receipt of final approval for Taro's NDA filing for ElixSure(TM) IB. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurances that its expectations will be attained. Factors that could cause actual results to differ include general economic conditions, industry and market conditions, slower than anticipated penetration of new markets, changes in the Company's financial position, regulatory actions and legislative actions in the countries in which Taro operates, including actions related to ElixSure(TM) IB, future demand and market size for products under development, marketplace acceptance of any ElixSure(TM) product, 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.


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

    SOURCE: Taro Pharmaceutical Industries Ltd.
Terms of Use
|
Privacy Statement
|
Safe Harbor Statement