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Upjohn's Depo-Provera C-150 (depomedroxyprogesterone acetate, or DMPA), a long-acting injectable contraceptive, was unanimously recommended for approval by FDA's Fertility and Maternal Health Drugs Advisory Committee at its June 19 meeting. The approval recommendation followed almost 20 years of controversy over whether the drug is a safe and effective contraceptive. Commenting on whether Depo-Provera should be approved, committee member Ezra Davidson, MD, Charles D. Drew Postgraduate Medical School, Los Angeles, stated: "I am impressed first by the unchallenged efficacy of the drug, which is, across-the-board, probably better and [has] less risk and inconvenience associated with it than any other contraceptive." Upjohn consultant Amy Pollack, MD, said Depo-Provera is 99% effective. Davidson said that given that the drug has been used for many years in many countries, "If there were major problems with it, we should be seeing more clinical events that are of significance. That's not to minimize the fact that there is genuine scientific concern in continuing to explore what the long-term effects are." Upjohn says DMPA has been used by 30 mil. women worldwide in more than 90 countries and over 100,000 women have taken the drug for more than 10 years. Committee member Dorothy Barbo, MD, University of New Mexico School of Medicine, commented: "While we do not have all the information we would like, I think we have a fair amount of data for the use of this drug. And I think it's one more contraceptive option that we have for some patients." Given as an injection once every three months, Depo-Provera costs about $120 a year, or $30 per 150 mg injection, according to Andrew Kaunitz, MD, Family Health Services, Jacksonville, Fla., an Upjohn consultant who spoke on Depo-Provera's clinical experience in the U.S. Barbo reiterated that DMPA is "something we do need to strongly consider...having available," although she noted that "the informed consent option and patient education are essential." Barbo also endorsed the idea of conducting studies on the drug's long-term effects. The original Depo-Provera NDA was filed in 1967 and was subsequently withdrawn in 1986 so that future data on whether the contraceptive is associated with an increased risk of cancer could be included in a new NDA. Concern over the safety of Depo-Provera was raised in 1973 when beagle dogs in carcinogencity studies were found to have invasive adenocarcinoma in mammary nodules. A new drug application for DMPA was resubmitted on April 30, 1992 following the publication in 1991 of findings from a nine- year World Health Organization study of more than 11,000 women. It concluded that Depo-Provera showed no overall increased risk of cancers. The study also concluded that Depo-Provera and oral contraceptives carry similar risks of breast cancer. * Guiding the committee, FDA Division of Metabolism and Endocrine Drugs Director Solomon Sobel, MD, said that although FDA decided that the results of the WHO study do not support "an appreciable risk" for breast cancer, "we want the committee to make an independent judgment of the WHO findings primarily, and of course address the more recent findings of other problems." He noted that, based partly on the results of the WHO study, FDA concluded that beagle dog toxicological studies of steroidal contraceptives are no longer required since they are not relevant to humans. Addressing recent findings that Depo-Provera may decrease bone density with long-term use, committee member Barbo said: "I'd like to recommend that we have Phase IV studies on patients on [Depo- Provera] long term." Jennifer Niebyl, MD, University of Iowa School of Medicine, recommended that these potential risks should be part of physicians' informed consent practices. The committee was also concerned with the possibility that Depo-Provera may cause low birth weight in infants. Committee Chairwoman Barbara Hulka, MD, University of North Carolina School of Public Health, said: "The committee recommends...that the labeling by very clear about timing the injections during the menstrual cycles so pregnant women [don't get] DMPA." Committee members also suggested that the potential for low birth-weight babies of women inadvertently treated with DMPA while pregnant be studied. The June 19 meeting marked the third time Depo-Provera had gone before an FDA advisory committee. The progesterone was recommended for approval in 1973 and again in 1975 by the Obstetrics and Gynecology Advisory Committee for a limited patient population. DMPA is currently approved for the treatment of endometrial and renal cancers.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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