Makena Generic Launched
June 25, 2018 – American Regent has launched its generic to AMAG Pharma USA’s Makena® (hydroxyprogesterone caproate injection) 250mg/mL. The product is indicated to reduce the risk of preterm delivery for women who are pregnant with one child and have a history of preterm spontaneous single child delivery. It is not indicated for women who are pregnant with more than one child, or who have other risk factors for preterm births.
Hydroxyprogesterone caproate injection 250mg/mL should be administered by a healthcare professional via intramuscular injection. Recommended dosing is one single-dose vial given once per week, starting between weeks 16 and 21 of pregnancy and continuing until week 37 or the birth of the child.
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.