Reversing sedative effects of benzodiazepines News

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April 25, 2004 03:25 AM US Eastern Timezone

Teva Announces Tentative Approval of Flumazenil Injection

JERUSALEM--(BUSINESS WIRE)--April 25, 2004--Teva Pharmaceutical

Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and

Drug Administration has granted tentative approval for an ANDA for

Flumazenil Injection, 0.1 mg/mL, which was submitted by the Company's

subsidiary SICOR Inc. Final approval of this product is expected upon

expiration of patent protection on October 10, 2004.

Flumazenil Injection is the generic equivalent for HLR Technology's

Romazicon® Injection, a product used to reverse the sedative effects

of benzodiazepines.

The brand product has annual sales of approximately $40 million.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among

the top 30 pharmaceutical companies and among the largest generic

pharmaceutical companies in the world. The company develops,

manufactures and markets generic and innovative human pharmaceuticals

and active pharmaceutical ingredients. Close to 90% of Teva's sales are

in North America and Europe.