The US Food and Drug Administration has reported that the availability of the gonadotrophins Pergonal (menotrophin) and Metrodin (urofollitrophin) in the USA have been adversely affected by manufacturing decisions taken by Serono, which produces both drugs.
The company said that as a result of an increase in production of highly-purified follicle stimulating hormone and luteinizing hormone for use in its newer products, there has been a corresponding decrease in the raw materials to make the current versions of the drugs.
In order to try and remedy the shortages, the agency says that it is in discussions with Serono to try and expedite the return of these infertility drugs to the USA. The FDA also reported that it will consider an additional manufacturing facility application so that production of the drugs can be resumed.
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