Wednesday 26 December, 2007

USFDA issued a second approvable letter for bazedoxifene

The USFDA issued a second approvable letter for bazedoxifene, an estrogen receptor modulator being developed by Wyeth to prevent postmenopausal osteoporosis.
In its letter, the FDA identified several remaining questions regarding issues that had been previously identified during the review process and that were not fully resolved by Wyeth's complete response to the first approvable letter.

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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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