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1. AMAG: FDA decision on Feraheme in a Few Days
By Adam Feuerstein
6:28 a.m. EDT
AMAG Pharmaceuticals (AMAG) expects the FDA to announce an approval decision on its IV iron replacement product Feraheme "within the next few days," the company said Monday night, based on contact from the regulatory agency. The FDA's decision was supposed to come Monday.
The FDA has not requested any additional information from AMAG and no outstanding issues remain regarding Feraheme, according to the company.So, what does this all mean for AMAG? Two possible scenarios: First, this latest delay is simply an administrative backlog at the FDA. It is taking longer than expected to get all the signatures and sign-offs necessary for Feraheme's full approval, so this latest, short delay is no big deal. Second, the FDA does have a significant (and unidentified) problem with Feraheme's approval so the drug is now in regulatory limbo. A delay could stretch on for months, as has happened with Cardiome's (CRME) drug for atrial fibrillation. I fear the second scenario, of course, but I doubt it. An administrative holdup at the FDA is the more likely reason for this delay, so I wouldn't panic. Longtime followers of AMAG have already built up their calluses over the past six months or so; a few more days is not too long to wait. AMAG is holding a conference call at 8:30 a.m. EDT. No positions.
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