The Food and Drug Administration (FDA) has granted approval to Gemmily™ (Xiromed), a therapeutic equivalent to Taytulla ® (Allergan), an estrogen/progestin combination oral contraceptive indicated for use by women to prevent pregnancy.
Gemmily contains 24 active capsules containing 1mg of norethindrone acetate and 20mcg of ethinyl estradiol and 4 capsules containing 75mg of ferrous fumarate (nonhormonal placebo). The product is supplied in a package of three blister cards that contain 28 soft gelatin capsules and is expected to be available soon.
“The Xiromed team is excited to offer this first generic product, furthering our commitment to providing high quality generics to patients in the US,” Narasimhan Mani, CEO of Xiromed.
In 2016, Allergan launched Taytulla as the first oral contraceptive available in a softgel capsule formulation.
For more information visit xiromed.com.
Xiromed LLC launches Gemmily™, first-to-market generic to Taytulla®. [press release]. Florham Park, NJ: Xiromed; November 9, 2020.