New Indications Approved for Norditropin
February 23, 2018 – The U.S. FDA has approved two new indications for Norditropin® (somatropin) injection, manufactured by Novo Nordisk. A growth hormone, Norditropin can now be used to treat children who have a short stature with no known cause (idiopathic short stature), as well as children who have experienced failure to grow due to Prader-Willi syndrome.
Norditropin was first FDA approved in 1987. In addition to the new indications, it is approved to treat growth failure in children who have inadequate secretion of growth hormone, short stature associated with Noonan syndrome or Turner syndrome, and short stature associated with having been born small for their gestational age and no catch-up growth by ages 2-4 years old. The drug is also approved as a replacement for endogenous growth hormone in adults who have growth hormone deficiency.
Recommended dosing is based on factors including weight, age, and indication.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.