Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661
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Abstract
The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests for estrogen-androgen fixed- combination drug products under Docket FDA-1998-P-0083 (formerly 76N- 0377) (DESI 7661) have been withdrawn. Therefore, as proposed in the April 14, 2003, notice of opportunity for hearing (NOOH), FDA finds that the products subject to this proceeding have not been shown to be effective for use under the conditions of use prescribed, recommended, or suggested in the labeling. Shipment in interstate commerce of any product identified in this docket (DESI 7661), or any identical, related, or similar (IRS) product, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful as of the date of this notice.
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