Lek's comeback to the American market
FDA approval of re-launching cimetidine
Ljubljana, 11 May – The American Food and Drug Administration approved that Slovene pharmaceutical company re-launch the generic drug cimetidine on the US market.
Cimetidine tablets that Lek will re-launch in the US market both as a prescription and a non-prescription drug, are used in gastric disorders.
This is one of the three products Lek recalled from the US market of its own free will in March 1999 because of the FDA requirements to supply additional documentation on the performed clinical studies that served as a basis for the registration of three finished products; throughout that time, however, Lek marketed there its pharmaceutical active ingredients.
In the highly demanding competitive environment of the American generic pharmaceutical market, the most developed pharmaceutical market in the world, Lek is restoring with its cimetidine its market position in the USA. The sales of Lek’s cimetidine will start again in summer. According to our estimates, the market share obtained in the past will be regained in the following year.
The FDA re-approval of re-launching of cimetidine in the US market confirms Lek’s acting in conformity with strict international requirements of pharmaceutical industry and the effectiveness, quality and safety of its products.
This press release contains the statements and forecasts of Lek’s future business operations. The forecasts feature the assessments formed on the basis of all the information currently available. Should these forecasts turn out to be unreliable, the actual business results would be different from the anticipated.