Citizen Petitions Blocking ANDAs Prevented Under Proposed Rule

FDA decisions on ANDAs or 505(b)(2) applications would not be delayed by pending citizen petitions, or petitions for stay of action, unless a delay is necessary to protect public health, under a new proposed rule. The rule could signal a victory for the generic-drug industry by making it more difficult for brand drugmakers to block generic competition, an industry attorney said. The FDA receives about 32 petitions each year challenging the approvability of an ANDA or 505(b)(2) application, according to the proposed rule.
Generic Line