FDA approval sought for Ferring Pharmaceutical’s ZOMACTON

Ferring Pharmaceuticals affirmed that the U.S FDA has sanctioned ZOMACTON for injection 5 mg and 10 mg recombinant human growth hormone implied for replacement of GH in adults with GH deficiency. ZOMACTON is also indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.

Adult growth  hormone deficiency occurs in approximately 1-2 adults per 100,000 and can be a continuation of childhood onset growth hormone deficiency or have an onset in adulthood resulting primarily from trauma, surgery or radiation to the head. ZOMACTON continues to be available by prescription in the U.S., offering both 5 and 10 milligram (mg) options, with the 10 mg dose in a pre-filled diluent syringe. In addition, the ZOMA-Jet needle-free administration device is also available for the 5 mg dose.

Paul Navarre, CEO, Ferring Holding Inc said “We are pleased to add the adult indication to our existing endocrinology portfolio.”

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