A: THE 505(B)(2) NEW DRUG APPLICATION (NDA) encourages sponsors to file somewhat streamlined regulatory submissions in which at least some of the information relies on the FDA’s findings of safety and effectiveness of a similar, previously approved, reference drug and data available in the public domain. A 505(b)2 NDA contains bridging studies comparing the new drug with the reference drug. In addition, sponsors must still provide preclinical or clinical data to ensure that the new formulation/form/route of administration does not compromise safety and provides efficacy. This effective business model takes less time, cost, and risk to get product onto the market because the active ingredient has been previously approved with data from a prior submission package. Depending on the extent of the change to the previously approved drug and the type of clinical data included in the NDA, it is possible to qualify for three or five years of market exclusivity for the new drug.
MITCHELL KATZ, PH.D.
Mitchell is head of clinical research and drug safety operations at Purdue Pharma L.P.