SOV Therapeutics Receives U.S. Orphan Drug Designation for the Use of Oral Testosterone Undecanoate in the Treatment of Constitutional Delay in Growth and Puberty in Adolescent Boys (14-17 Years of Age)
2/20/2013 10:48:36 AM
MORRISVILLE, N.C.--(BUSINESS WIRE)--SOV Therapeutics Inc. 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). The US Orphan Drug Designation program provides orphan status to drugs intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US. Orphan designation by the FDA qualifies the sponsor for incentives provided for in the Orphan Drug Act, which can include design support for clinical trials, fee waivers, tax incentives, eligibility for expedited review, and seven years of market exclusivity upon approval.