Valeant Wins Stay On Efudex Generic
This article was originally published in The Pink Sheet Daily
In an abrupt reversal, FDA tells court it will review approval of Spear’s fluorouracil ANDA and make a decision by May 30.
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The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter