New Indication for Zomacton
January 29, 2018 – The U.S. FDA has approved a new indication for Zomacton® (somatropin), manufactured by Ferring Pharmaceuticals, Inc. The product is now approved as a growth hormone (GH) replacement for adults who have growth hormone deficiencies.
Originally approved in 1995, Zomacton is also indicated to treat pediatric patients with growth failure due to inadequate secretion of endogenous GH. It must be administered via subcutaneous injection in one of four specified injection sites, and the site of injection should be rotated regularly. Recommended dosing depends on the age, weight, and indication, and specific requirements of each patient.
Zomacton is available in two strengths for reconstitution: a 5 mg vial of Zomacton powder with a 5mL vial of bacteriostatic 0.9% sodium chloride, and a 10mg vial with a syringe of 1 mL of bacteriostatic water. The 10mg dosage is available with either a 25g reconstitution needle, or a vial adapter.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- 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.