FDA Approval of Zimulti Acomplia. Aproved in EU waiting in USA

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FDA APPROVAL FOR RIMONABANT

The US Food and Drugs Administration did not approve the induction of Rimonabant (Acomplia) in the markets of the USA. It is true that the National Institute of Health has very high standards but the theoretical parameters must be applied after due examination of the product and its risk and benefit profile.

Rimonabant (Acomplia) has been in use in Europe under the brand name of Acomplia and has been approved by the drug authorities of the European Union and UK. The FDA in USA chose not to approve the induction of Rimonabant (Acomplia) by expressing misgivings on the products clinical outcome. This was not very fair considering the fact that the request for approval was turned down without seeking proof and clinical data to authenticate the claims of the manufacturers.

This is a typical example of adherence to rules without application of the mind. A recent case of the bureaucratic processing of drugs for the US markets needs to be cited to explain the FDA mindset. Redux, an appetite control drug was introduced for US markets. This was the new garb for the old and ineffective medication based on fenfluramine which was itself withdrawn two years later because of pulmonary hypertension and epidemic obesity in patients. So a drug which was withdrawn was approved once again because the applicant called the product by a different name withholding the information about the reasons for the withdrawal of their block buster drug. There were no pre approval trials and the expensive product was approved with cosmetic changes.

Rimonabant (Acomplia) has since then withdrawn its application and is about to apply to the FDA afresh for marketing Rimonabant (Acomplia) under the brand name of Zimulti.

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