FDA OKs Expanded Label of Abbott Laboratories (ABT)'s Treatment for Premature Puberty
10/31/2011 8:35:36 AM
The US Food and Drug Administration (FDA) have approved Abbott’s supplemental New Drug Application (sNDA) for Lupron Depot-PED (leuprolide acetate for depot suspension). The one-month formulation is the first product in its class to include long-term data in its label for the treatment of central precocious puberty (CPP), a condition which causes children to enter puberty too soon. The prescribing information now contains 18 years of data, including pre-specified outcome results on puberty, height and reproductive function.
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