Triptodur Approved to Treat Central Precocious Puberty
June 30, 2017 – The U.S. FDA has approved Triptodur™ (triptorelin) extended-release injectable suspension, which is distributed in the U.S. by Arbor Pharmaceuticals. Triptodur is a gonadotropin releasing hormone (GnRH) agonist approved to treat children at least two years of age for central precocious puberty. Triptodur is packaged as a powder that will be reconstituted and administered by a healthcare professional as one 22.5mg intramuscular (IM) injection every 24 weeks. Children using Triptodur should be monitored every few months for bone age, height, and blood sex-steroid levels. Arbor Pharmaceuticals plans to launch Triptodur in the fourth quarter of 2017.
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.