Wednesday, 6 August 2008

Alendronate Sodium: Aurbindo got final approval

Hyderabad based Aurbindo Pharma has announced that the company has recieved final approval to market Alendronate Sodium trihydrate tablets (Generic equivalent of Merck's Fosamax) for 10mg, 35mg and 70mg. Alendronate Sodium trihydrate is indicated for the treatment of osteoporosis. Aurbindo is the first company to recieve approval after the expiry of combined 180 days exclusivity of Barr and Teva (which ended on 6th August). The Aurbindo's ANDA was reviewed with in 8 months by USFDA. Eralier, Barr and Teva launched their product in February, 2008, after the expiry of product patent.

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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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