Thursday, 16 April 2009

Zoledronic acid (ZOMETA) lyophilized powder for injection: USFDA confirmed that drug was not withdrawn due to safety issues

The USFDA has determined after review of citizen petition (filed on Spetember, 2007) by generic player Sun Pharma (through Kendle international) that ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams (mg) base/vial, lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness.
Eralier, Innovator Novartis discontinued manufacturing and marketing this product in May, 2003. This decision will allow USFDA to approve ANDA's for this product

Posted by ADKS at 5:54 pm

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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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