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Taro Receives ANDA Approval For Extended Phenytoin Sodium Capsules, USP 100mg |
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07 Sep 2006 |
Extended Release Capsules are Generic Equivalent to Pfizer's Dilantin(R) Kapseals(R)
HAWTHORNE, NY, USA | Sep 06, 2006 | Taro Pharmaceutical Industries Ltd. ("Taro") (Nasdaq:TARO) reported today that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Extended Phenytoin Sodium Capsules, USP 100mg ("extended-release phenytoin capsules").
Taro's extended-release phenytoin capsules are a prescription product used for treating seizures related to epilepsy and neurosurgery. The new Taro product is bioequivalent to Pfizer's Dilantin(R) Kapseals(R). According to industry sources, extended-release phenytoin capsule products have annual U.S. sales of approximately $191 million.
First ANDA Approvals for Ireland Facility
In addition, in August 2006, Taro Pharmaceuticals Ireland Ltd., Taro's Irish affiliate, received approvals from the FDA for its ANDAs for Sodium Chloride Injection USP, 0.9% and Water for Injection, USP, packaged in single-dose plastic ampules. These products are bioequivalent to the comparable products of Hospira, Inc. and are the first two ANDA approvals received by Taro's Irish affiliate. These sterile injectable prescription products are widely used in hospital and medical practice.
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 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 new extended-release phenytoin capsules, sterile water for injection and sodium chloride injection 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; marketplace acceptance of the new Taro 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 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.
CONTACT: Taro Pharmaceutical Industries Ltd. |
