Restrictive FDA Requirements and the Development of Generic Topical Medications—Reply

In Reply We thank Mollanazar for the interest in our study and agree that the existing requirements by the US Food and Drug Administration (FDA) may deter the entrance of generic manufacturers for topical dermatology drugs. Specifically, the author references the considerable financial resources and time required for in vivo bioequivalence studies prior to drug approval, while noting recent and incremental progress in which the FDA allowed in vitro testing for acyclovir. Among topical medications, in vitro testing to establish bioavailability and bioequivalence usually requires the tested drug to be qualitatively and quantitively similar to the reference listed drug, in addition to possessing comparable physicochemical properties, release rates, and permeation characteristics.

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