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Ema, generics suspended supported by unreliable studies

The EMA (the European Medicines Agency) has suspended the marketing authorization of seven equivalent medicines due to the unreliability of the supporting clinical studies. The decision came on September 20, after completing a review of nine medicines, following concerns about the way in which the studies presented for their applications for marketing authorization had been conducted. This was announced by Aifa (Italian Medicines Agency) from its website. The studies in! Those involved were all conducted at the Cetero research facility in Houston, Texas, where the Food and Drug Administration carried out inspections on the laboratory analyzes of some so-called "bio-analytical" studies carried out between 2005 and 2010. It emerged that the results of these studies cannot be considered reliable, therefore the EMA asked the CHMP (Committee for Products for Human Use) to make an assessment. The CHMP concluded that for seven medicines (Cilaprazil Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva, Ribavirin Teva Pharma), used for hepatitis C, hypertension, cholesterol and rheumatoid arthritis, some studies presented in support of their authorization are unreliable. Therefore, their marketing authorization will be suspended until adequate data are submitted. For Temodal and Tygacil (used for a type of brain tumor and abdominal infections) the results have no impact on the benefit-risk profile of these medicines and no further action is needed. The CHMP recommendations have been sent to the European Commission, which will issue an opinion on the suspension of the affected medicines. However, the EMA does know that no safety problems have been found with any of these medicines on the market. Patients who are taking any of the suspended generic medicines should be advised about alternative treatments.

September 28, 2012 – DoctorNews

Questions and answers on the review of nine centrally and nationally authorized medicines (21/09/2012)


The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has completed a review of nine centrally and nationally authorized medicines, following concerns about how the laboratory analyzes of some of the studies submitted under the

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco