The Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for Merzee (Slayback Pharma), an AB-rated generic equivalent of Taytulla® (Allergan), an estrogen/progestin combination oral contraceptive indicated for use by women to prevent pregnancy. The efficacy of Merzee in women who are obese (BMI >35kg/m2) has not been evaluated.

Merzee 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 will be supplied in blister cards containing 28 soft gelatin capsules and is expected to be available soon.

The approval was designated a Competitive Generic Therapy, meaning the Company will have 180-day exclusivity to market the product from the date of the first commercial launch of Merzee.

For more information visit slayback-pharma.com.

References

  1. Slayback Pharma announces FDA approval of Merzee, generic equivalent of Taytulla® with a Competitive Generic Therapy (CGT) Designation. [press release]. Princeton, NJ: Slayback Pharma LLC; December 18, 2020. 
  2. Merzee [package insert]. Princeton, NJ: Slayback Pharma LLC; 2020.