Latebreakers: Low-dose estrogen gel granted approval

June 18, 2007

Upsher-Smith Laboratories will market the lowest available dose of estradiol gel for the treatment of moderate to severe vasomotor symptoms associated with menopause following the FDA approval of Divigel 0.1%.

Upsher-Smith Laboratories will market the lowest available dose of estradiol gel for the treatment of moderate to severe vasomotor symptoms associated with menopause following the FDA approval of Divigel 0.1%. The topical formulation contains 17 beta-estradiol and is quick-drying and odorless, according to the manufacturer. Divigel will be supplied in single-dose foil packets of 0.25, 0.5, and 1 gm, containing 0.25, 0.5, and 1 mg of estradiol, respectively, and should be applied daily to an area that measures five by seven inches on the thigh. In trials, both the 0.5- and 1-gm treatment groups had a statistically significant reduction in frequency and severity of vasomotor symptoms by week four and, in the 0.25-gm group, by week seven of treatment.