Nutropin® (somatropin (rDNA origin))

BL 019676

Nutropin® (somatropin (rDNA origin))

BL 019676

U.S. License Holder:

Genentech

Date of License:

March-09-1994

Last Update:

Sep-30-2024

approved_indications FDA-Approved Indications

NUTROPIN (somatropin) is indicated for the treatment of:

Pediatric Patients:

Growth Hormone Deficiency (GHD);

Growth Failure Secondary to Chronic Kidney Disease (CKD);

Idiopathic Short Stature (ISS);

Short Stature Associated with Turner Syndrome (TS);

Adult Patients:

For the replacement of endogenous GH in adults with GHD who meet eitherof the following two criteria: Adult Onset: Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or Childhood Onset: Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

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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