Kyleena Long-Acting Contraceptive Approved
September 16, 2016 – The US FDA approved Kyleena™ (levonorgestrel-releasing intrauterine system). Manufactured by Bayer Pharmaceuticals, Kyleena is a long-acting reversible contraceptive (LARC). Kyleena is an intrauterine device (IUD) that must be inserted and removed by a healthcare provider to prevent pregnancy for up to five years by slowly releasing a low dose of progestin. It may be removed earlier, if needed; and it does not affect fertility after removal. Bayer plans to launch it in October 2016 and it will be available through a limited network of specialty pharmacies.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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.