AI
Friday, August 06, 2010 7:32:17 AM
it’s actually closer to 7.5 years since Teva submitted its Lovenox ANDA. Teva notified SNY (then d/b/a Aventis Pharmaceuticals) of its Paragraph-IV challenge in Jun 2003, following FDA acceptance of Teva’s ANDA for review.
It sure took them a long time to act arbitrarily and capriciously.
ij
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)
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