FDA has opened a public docket to request comments on its newly proposed criteria for "first generic" abbreviated new drug application ("ANDA") submissions. There are two criteria for a "first generic" ANDA for the purposes of review prioritization: (i) a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (ii) for which there is no previously approved ANDA for the drug product. FDA stated that "[e]stablishing clear criteria for this review prioritization category will allow FDA to appropriately prioritize ANDA submissions and track them in a manner consistent with the review prioritization commitments FDA made pursuant to GDUFA." FDA also hopes to stem industry confusion with clearer criteria and promote "more consistent identification of 'first generic' submissions." FDA specifically seeks comments on whether FDA should change the review prioritization for an ANDA that no longer meets the "first generic" criteria during its review, e.g., the validity of a patent may be upheld in litigation, thereby blocking approval until patent expiry. Comments due December 19, 2014.
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