BTG's BioTropin Approved In USA
The US Food and Drug Administration has approved Israeli company Bio-Technology General's recombinant human growth hormone product BioTropin. It is indicated for the treatment of children with small stature. This is the first US approval of a BTG product, and is the latest development in a long battle to bring BioTropin to market.
In January, the US International Trade Commission dismissed a claim by competitor Genentech that BTG's product infringed some process patents. Another patent litigation in a US federal district court is still outstanding, but this will not prevent BTG launching the drug. The market for hGH products in the USA is around $300 million a year.
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