Lek co-operates with FDA
Because the U.S. FDA (Food and Drug Administration) required additional clinicial data, Lek has voluntarily discontinued the distribution of its products for which a distribution licence for the American market had already been issued, for the period until the re-submission and approval of the above mentioned documents. This measure only applies to the following generic drugs: Bromokriptin tablets and capsules, Cimetidin tablets, and Aciklovir tablets and capsules. Lek anticipates requresting expedited consideration by the FDA of these matters.
The FDA issued its new requirements after the re-examination of the documentation submitted in the process of granting distribution licences, although these licences have already been issued in line with then-existing procedure. Together with the American consultants, Lek will co-operate with the FDA and perform all the necessary activities in order to reobtain necessary approvals, as well as obtain approvals for new drug products.
For the execution of the necessary procedures and for their confirmation, some time will be needed, therefore we expect a certain reduction in the anticipated sales and profits in this year. As long as the discussions with the FDA and customers are not concluded, it is impossible to assess the value of the possible loss of sales, since it depends on the final decision by the FDA, which is difficult to foresee. In the worst possible scenario, this could mean a reduction in the planned sales by a maximum of US$12-14 million this year.
According to our assessment, these circumstances will pose no serious threat to the development of new products that are an important factor in future business growth in the U.S. and other markets.