Regulatory Actions

Teva Announces Tentative Approval of Famciclovir Tablets

Published in FDA Law Weekly, July 19th, 2007

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Famciclovir Tablets, 125 mg, 250 mg and 500 mg. Final approval of this application is anticipated on August 24, 2007, upon expiry of the mandatory stay of approval associated with patent litigation related to this application.

The brand product had annual sales of approximately $190 million for the twelve months ended March 31, 2007, based on IMS sales data.

Keywords: Drugs, Famciclovir, Pharmaceuticals, Regulatory Actions, Therapy, Treatment, Teva Pharmaceutical Industries.

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Source: FDA Law Weekly (2007-07-19)

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