Humatrope® (somatropin)

BL 019640

Humatrope® (somatropin)

BL 019640

U.S. License Holder:

Eli Lilly

Date of License:

October-16-1986

Last Update:

November-23-2020

approved_indications FDA-Approved Indications


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

Pediatric Patients: Treatment of children with short stature or growth failure associated with growth hormone (GH) deficiency, Turner syndrome, idiopathic short stature, SHOX deficiency, and failure to catch up in height after small for gestational age birth;

Adult Patients: Treatment of adults with either childhood-onset or adult-onset GH deficiency.

Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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