PARSIPPANY, N.J., Jan. 31, 2018 /PRNewswire/ -- Ferring Pharmaceuticals Inc. today announced that the U.S. Food and DrugAdministration (FDA) has approved ZOMACTON® (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.
Adult growth hormone deficiency (GHD) 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.i GHD in adults is characterized by metabolic dysfunction, reduced physical strength and activity, altered lipid metabolism and increases in body fat.ii
ZOMACTON is also indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
"This expanded indication offers an important option that I can now offer my adult patients who need human growth hormone treatment," said Ron Rosenfeld, MD, Professor and Chair of Pediatrics (Emeritus), Oregon Health & Science University.
In 2015, the FDA granted approval for ZOMACTON to be marketed in the U.S. for injection and its needle-free delivery system as ZOMA-Jet®. Ferring developed and has marketed ZOMACTON outside of the U.S. since 1988 and in 47 countries globally.
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.
"Ferring is committed to developing treatments that improve people's lives," said Paul Navarre, CEO, Ferring Holding Inc. "We are pleased to add the adult indication to our existing endocrinology portfolio."
Consistent with the Ferring Philosophy that "People come first," Ferring is offering ZoGo support services to new adult ZOMACTON® patients, providers and caregivers. The ZoGo program has been in place since 2015. For more information, call 1-844-944-ZOGO (9646).
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch, or call 800.FDA.1088.
For full prescribing information, please visit: www.ferringusa.com/pi/zomacton
About Ferring Pharmaceuticals Inc.Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, urology, gastroenterology, endocrinology, women's health and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com or www.ZOMACTON.com
ZOMACTON® (somatropin) for Injection is a recombinant human growth hormone (GH) indicated for:
Important Safety Information
ZOMACTON® is contraindicated in patients with:
WARNINGS AND PRECAUTIONS
Most common adverse reactions (10% or greater incidence) in adult and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, parethesia, myalgia, pain, rhinitis, peripheral edema, back pain, flu syndrome, and AST increased.
USE IN SPECIFIC POPULATIONS
ZOMACTON® and ZOMA-Jet® are registered trademarks of Ferring B.V.
For further information:
Media ContactAna Fullmer202-530-4662Ana.Fullmer@bm.com
i Manthan Life Sciences Consulting Report for Ferring. June 22, 2017.
ii Attanasio AF, Lamberts SW, Matranga AM. Adult growth hormone (GH) deficient patients demonstrate heterogeneity between childhood onset and adult onset before and during human GH treatment. J Clin Endocrinol Metab. 1997 Jan;82(1):82-8.
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SOURCE Ferring Pharmaceuticals Inc.
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