Natco Pharma has got tentative approval from USFDA to market Anastrozole Tablets (Arimidex , 1mg) . Although, 8 generic players has got tentative approval on this product but generic will only be available after expiry of following Orange Book listed patent:
USRE36617 (Jun 27, 2010): which covers Anastrozole as product
Following generic players has got tentative approval
1.Teva (February 26, 2008)
2.Synthon (May 25, 2007)
3.Roxane (June 28, 2007)
4. Zydus (April 29, 2008)
5. Stason (November 13, 2008)
6. Watson (April 24, 2008)
7. Sandoz (June 25, 2008)
8. Natco (November 7, 2008)
Innovator got approval from USFDA to market Arimidex (Asnastrozole) on Dec 27, 1995.
Monday, 17 November 2008
Arimidex (Asnastrozole): Natco Pharma got tentative approval
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