Teva Announces Tentative Approval Of Generic Femara(R) Tablets

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Cancer / Oncology
Article Date: 22 Jan 2010 - 21:00 PDT


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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' breast cancer treatment Femara® (letrozole) Tablets, 2.5 mg. Final approval of Teva's Letrozole Tablets is expected upon expiry of patent protection for the brand product in June 2011.

The brand product had annual sales of approximately $556 million in the United States, based on IMS sales data.

Source
Teva Pharmaceutical Industries Ltd.

View drug information on Femara.


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