Omnitrope® (somatropin)

aBL 021426

Omnitrope® (somatropin)

aBL 021426

U.S. License Holder:

Sandoz

Date of License:

May-30-2006

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

OMNITROPE (somatropin) is a recombinant human growth hormone indicated for:

Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature;

Adult: Treatment of adults with either adult onset or childhood onset GHD.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Omnitrope® (Sandoz) (April-2009)

Biosimilars Approved In The E.U.

Omnitrope® (Sandoz) (April-2006)

Biosimilars Approved In Australia

Omnitrope® (Sandoz) (September-2010)

Biosimilars Approved In Japan

Somatropin BS (Sandoz) (June-2009)

Biosimilars Approved In South Korea

Omnitrope® (Sandoz) (June-2009)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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