2 Traps For Unwary ANDA Filers

Law360, New York (January 2, 2014, 6:04 PM EST) -- Companies looking to file an abbreviated new drug application ("ANDA") in 2014 should be aware of two draft guidances issued by the U.S. Food and Drug Administration this month. The draft guidances address bioequivalence standards for ANDA products and physical attributes of generic tablets and capsules, respectively.

Companies that are not aware of these guidances not only risk the FDA refusing to approve its generic product, but also citizen petitions and possible litigation that would impede the launch of their generic alternatives. An ANDA applicant that...
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