http://pharmaweblog.com/blog/2006/11/13/galvus-fda-review/ Pharmaceutical and biotech science and business Wed, 20 Aug 2008 11:14:09 +0000 http://wordpress.org/?v=2.0.2 http://pharmaweblog.com/blog/2006/11/13/galvus-fda-review/#comment-171 Sat, 17 May 2008 02:14:31 +0000 http://pharmaweblog.com/blog/2006/11/13/galvus-fda-review/#comment-171 [...] It’s looking like Merck got an incredibly lucky break here: Januvia sailed through FDA approvals and has come charging out of the gate with an “enormously successful start” (10% of new diabetic prescriptions). Meanwhile, its competitor from Novartis, Galvus, has been held up with the FDA for safety concerns. Hmmm… [...] […] It’s looking like Merck got an incredibly lucky break here: Januvia sailed through FDA approvals and has come charging out of the gate with an “enormously successful start” (10% of new diabetic prescriptions). Meanwhile, its competitor from Novartis, Galvus, has been held up with the FDA for safety concerns. Hmmm… […]

]]> http://pharmaweblog.com/blog/2006/11/13/galvus-fda-review/#comment-46 Tue, 27 Feb 2007 20:59:10 +0000 http://pharmaweblog.com/blog/2006/11/13/galvus-fda-review/#comment-46 [...] When I reported on the initial Galvus approval delay in November, I promised a follow-up story.  Yesterday, Novartis reported that FDA took the action of granting the Galvus NDA approvable status.  Novartis had obviously expected this decision for a while, since label negotiations never occured, but the company chose to make the announcement after the decision was made official by FDA on the 23rd.  [...] […] When I reported on the initial Galvus approval delay in November, I promised a follow-up story.  Yesterday, Novartis reported that FDA took the action of granting the Galvus NDA approvable status.  Novartis had obviously expected this decision for a while, since label negotiations never occured, but the company chose to make the announcement after the decision was made official by FDA on the 23rd.  […]

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