Not FDA approved

As to claims that Somaderm Gel is FDA registered, ERSP determined that the marketer could make limited claims that were truthful and accurate. Specifically, the marketer could state that the marketer’s facilities are FDA registered and that Somaderm Gel has been assigned a National Drug Code (NDC) number. In its decision, ERSP noted that the advertising reviewed included detailed explanations regarding the NDC and registration of the facilities. However, ERSP also stated that the marketer should not include any claims that state or imply that the Somaderm Gel product is FDA approved

http://asrcreviews.org/hormone-gel-cannot-make-health-benefit-claims-somaderm-agrees-to-modify-discontinue-certain-claims-after-ersp-review-of-its-advertising/?