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January 30, 2015

Posted  January 25, 2016

Pharmaceutical company Laclede Inc. and its president Michael A. Pellico entered into a consent decree of permanent injunction concerning the distribution of unapproved over-the-counter vaginal drug products sold under the name Luvena Prebiotic. According to the government, Laclede’s sale and distribution of the Luvena Prebiotic products violated various provisions of the Federal Food, Drug, and Cosmetic Act because they did not have the required FDA approval. DOJ

Tagged in: Off-Label and Unapproved Use,