Generics Launched for Estrace Vaginal Cream
January 2, 2017 – Both Mylan and Teva have launched generics for Allergan’s Estrace® (estradiol 0.01%) vaginal cream, approved to treat moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Mylan announced the launch of its product on December 29, 2017. Teva’s launch was announced January 2, 2017.
The recommended dosing with estradiol 0.01% vaginal cream is anywhere from 2gm to 4gm applied topically in the vaginal area once a day for up to two weeks, before tapering down to a maintenance dose of 1gm used one to three times per week. The medication can be used either alone or with a progesterone replacement therapy.
All estradiol products, like other estrogen drugs, carry a black box warning that their use may lead to endometrial cancer, invasive breast cancer, increased risk of cardiovascular disorders, and dementia. The black box warning specifies that estrogens like estradiol should be used at the lowest possible dose and for the shortest possible duration, weighing treatment goals against risk to the patient.
IQVIA (formerly QuintilesIMS) reported that sales of Estrace vaginal cream in the United States had totaled $449 million in the twelve-month period that ended as of October 31, 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.