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by Robert MacKay, Sunday, 08 August 2010 | Categories: Reductil

Abbott has announced the voluntary withdrawal of their weight loss drug, Reductil, from the Australian market today. Doctors have been asked to stop filling out prescriptions and patients have been advised to discuss the alternatives with their prescribing doctor.

Reductil is a modest sized product for Abbott in Australia despite its popularity in the USA under brand name, Meridia, and the popularity the slimming pill once enjoyed in Europe. The FDA has yet to make a decision on whether Merida may remain licensed in the US but it does not seem in any particular hurry to withdraw the drug. If Sibutramine remains licensed in the US, then we believe that the European Medicines Agency will be approached to re-examine the license withdrawal of Reductil in the EU although we do expect the EU regulator to request specific information relating to the intended patient population in terms of safety and efficacy.

Australia’s Therapeutic Goods Administration (TGA) restricted the condition under which a Reductil prescription could be issued a few months ago. They reported that the drug’s safety and efficacy was still not clear amongst the patient group for whom it is intended. The drug was voluntarily pulled by Abbott after talks with the TGA.

Reductil is still available in New Zealand.





 
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