Today ANVISA, the Brazilian health authority with competence on the control of pharmaceutical products and APIs, banned the manufacturing, import, commercialization, manipulation and use of the API Lorcaserin. Lorcaserin is the drug substance of Belviq, an innovative weight-loss product that inhibits appetite by acting on the central nervous system. The drug was developed by Arena Pharmaceuticals.
In Brazil, APIs are registered independently of the drug products that contain them. API approval is needed to apply for marketing authorization of pharmaceutical products including them. (you can find here an overview of API registration) In this case, the API Lorcaserin had been approved by ANVISA in July 2013, but no commercial pharmaceutical products containing it were registered. The drug substance was being marketed only in customized compounded prescription medication, formulations prepared in pharmacy labs for individual patients.
Lorcaserin (commercialized as Belviq) was registered in the European Union until May 2013, but the…
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DRUG REGULATORY AFFAIRS INTERNATIONAL 