BioCentury
ARTICLE | Politics & Policy

FDA pushes generic competition for transdermal complex drugs

October 9, 2018 8:51 PM UTC

FDA clarified how to develop generic versions of transdermal or topical complex drugs, releasing a series of guidances Tuesday as the agency continues its push for greater generics competition.

Complex drugs, especially those with transdermal and topical formulations, often face less competition even after losing exclusivity because of the additional challenges for making generic versions, FDA Commissioner Scott Gottlieb said in a statement...