Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
FDA acknowledges that there are several challenges posed by the requirements set forth for generic ICs and has conceded that it is difficult to appropriately demonstrate bioequivalence on these measures. Moreover, because of the lack of a formal FDA-issued guidance describing the best approach to designing trials necessary to meet these requirements, FDA has not received many applications for these products regardless of the patent status on the reference product. 3 Based on communication with FDA’s CDER, until there is published FDA guidance, the Office of Generic Drugs (OGD) has advised that generic manufacturers can conduct their own studies to determine the methodology most appropriate to demonstrate bioequivalence, specifically the dose-response relationship. It is also recommended, however, that manufacturers discuss planned pharmacodynamic studies with OGD before initiating them, to ensure the design is adequate.