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  • Title: FDA review panel gives thumbs up to Norplant.
    Journal: Wash Memo Alan Guttmacher Inst; 1989 May 01; ():3-5. PubMed ID: 12290752.
    Abstract:
    On April 27, the Fertility and Maternal Health Drugs Advisory Committee of the US Food and Drug Administration (FDA) unanimously recommended that Norplant, a long-acting contraceptive implant, be given final FDA approval for marketing in the US. This comes after almost 20 years of research conducted around the world. It was also announced that Wyeth-Ayerst would be manufacturing Norplant for distribution in the US as well as marketing it in countries overseas. FDA officials expect final approval of Norplant, along with its labeling, to be completed within the next several weeks. Norplant will be introduced to the US market, however, only after a full-scale training program has been instituted to ensure enough well-trained providers for both insertion and removal. Wyeth company representatives plan to immediately begin working with experts at the Population Council, and they expect Norplant to be ready for marketing within a year. The final cost of the new method remains in question and detailed post-marketing surveillance studies need to be ready for implementation.
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