Gynex Pharmaceuticals Inc. announced Tuesday that FDA hadapproved its treatment investigational new drug (IND)application for using Oxandrin to treat Turner syndrome, agenetic disorder in females that results in short stature andlack of sexual development.
Published data indicate that Oxandrin (oxandrolone), usedalone or in combination with growth hormone, maysignificantly improve the growth rate of Turner syndromepatients, the Vernon Hills, Ill., company (NASDAQ:GYNX) said.
"The treatment IND process is designed to make significantpotential therapies for serious conditions available to patientsbefore clinical trials are completed," said Stephen Simes,president of Gynex. "This will allow Gynex to charge for thedrug in order to recover the cost of research, production anddistribution."
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