FDA To Initiate Full Review Of Bio-Technology General's Oxandrin

- Bio-Technology General of Israel has been advised by the US Food and Drug Administration that it is to initiate the full review of its testosterone analog Oxandrin (oxandrolone) for marketing approval. Oxandrin is thought to be beneficial in stimulating growth and may be used for the treatment of delayed puberty in males and Turner's syndrome in females, both conditions associated with growth disorders. The FDA has granted the company an Orphan Drug designation for these indications. Oxandrin is already marketed in the USA for the treatment of trauma-associated weight-loss.