Monday 17 November, 2008

Arimidex (Asnastrozole): Natco Pharma got tentative approval

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.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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