SOV received Orphan Drug Designation for the treatment of Constitutional Delay
in Growth & Puberty (CDGP) in Adolescent Boys (14-17 years of age) on Feb.
today announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for the use of oral testosterone undecanoate, a pro-drug of testosterone, in the treatment of Constitutional Delay
of Growth and Puberty (CDGP) in adolescent boys (14-17 years of age).
NASDAQ:BTGC) today announced that the United States Food and Drug Administration has accepted for full review and has initiated the review process for BTG's applications for approval to market Oxandrin(R) for both the treatment of constitutional delay
of growth and puberty (CDGP) in boys and Turner's syndrome, a genetic disorder in girls.
Under Treatment INDs, Oxandrin now can be prescribed as part of open clinical studies either for Turner syndrome or constitutional delay
of growth and puberty (CDGP) by pediatric endocrinologists or other physicians with experience in treating growth disorders.
In addition to now being commercially available for weight gain following weight loss, Oxandrin(R) is also available through Quantum under a treatment IND for two disorders affecting growth: constitutional delay
of growth and puberty (CDGP) in boys, and Turner's syndrome in young girls.
Gynex already holds a Treatment IND for Oxandrin in treating constitutional delay of growth and puberty, a growth disorder in boys.
The company also plans to submit NDAs for use of Oxandrin in treating constitutional delay of growth and puberty and Turner syndrome as clinical trials are completed, beginning in 1993.
The research is part of a family of studies on Turner syndrome in girls and constitutional delay of growth and puberty in boys now underway by the Gynex Cooperative Study Group.
Constitutional delay of growth and puberty is commonly diagnosed when the height, pubertal development and bone age of an otherwise healthy adolescent boy are significantly below average for chronological age.
In addition, the FDA has allowed a Treatment IND for Oxandrin as therapy for constitutional delay of growth and puberty in boys.
Published clinical reports in the medical literature suggest that Oxandrin, a testosterone analogue taken orally rather than by injection, may increase growth velocity in patients with Turner syndrome and constitutional delay of growth and puberty.
The by-elections were scheduled in 42 electoral constituencies for the provincial and national assemblies in the country after polling was called off in those seats because of the law and order situation and procedural or constitutional delays