Topical corticosteroid bioequivalence
This article was originally published in The Tan Sheet
FDA Generic Drugs Advisory Committee, along with representatives from the Dermatologic Drugs Advisory Committee, are scheduled to meet Sept. 12-13 to re-examine, in light of new experimental data and methods of analysis, a 1992 interim guidance issued by the Office of Generic Drugs on in vivo bioequivalence and in vitro release methods for topical corticosteroids. The committee will discuss the pharmacodynamic (i.e., vasoconstrictor) measurement of bioequivalence as well as other issues related to the documentation of equivalence, under the interim guidance. Discussion will be limited to dermatologic corticosteroids
You may also be interested in...
Perrigo promotes in pricing, planning
Combe sells most of its OTC brands
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC