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| Alias Born | 09/05/2002 |
Wednesday, November 14, 2007 8:40:16 PM
MNTA – The FDA approval of Mircera could be construed as a small positive sign for the Lovenox ANDA.
How so? Well, it shows that the FDA does not necessarily sit on an application just because there’s a blocking patent that runs for several more years.
Of course, it’s easier for the FDA to stall an ANDA than a BLA or NDA, but they have manifold ways of stalling any kind of application when they really want to. Hence, the Mircera approval suggests that the FDA may be willing to approve MNTA’s Lovenox ANDA—provided they are eventually satisfied on the immunogenicity issue—even if the Lovenox patent appeal is still pending.
Not exactly a strong inference, but every little but helps
How so? Well, it shows that the FDA does not necessarily sit on an application just because there’s a blocking patent that runs for several more years.
Of course, it’s easier for the FDA to stall an ANDA than a BLA or NDA, but they have manifold ways of stalling any kind of application when they really want to. Hence, the Mircera approval suggests that the FDA may be willing to approve MNTA’s Lovenox ANDA—provided they are eventually satisfied on the immunogenicity issue—even if the Lovenox patent appeal is still pending.
Not exactly a strong inference, but every little but helps
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