First Vagifem Generic Launched
October 17, 2016 - The first generic version of Vagifem®, manufactured by for Novo Nordisk, was released in the U.S. by Amneal Pharmaceuticals and is called Yuvafem® (estradiol vaginal inserts). Each insert of Yuvafem contains a low dose of estradiol intended to treat atrophic vaginitis (dryness, irritation, itching and pain) after menopause. Dosing is one insert per day for the first two weeks, then two inserts per week spaced about three days apart. Yuvafem will be dispensed in packages of eight and 18 inserts in disposable applicators. Its labeling carries boxed warnings common to all estrogens that indicates when used alone it may raise the risk of breast or endometrial cancers, blood clots or strokes. In addition, when used along with a progestin, estrogens may contribute to cardiovascular conditions and possibly to dementia. IMS Health estimates that sales of Vagifem totaled $423 million for the 12-month period ending July 31, 2016.
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.