Slayback Pharma has received final approval for its Abbreviated New Drug Application (ANDA) for Merzee (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1 mg/20 mcg from the U.S. Food and Drug Administration (FDA) with a Competitive Generic Therapy Designation. Merzee is an AB-rated generic equivalent of Taytulla®. Slayback is the "first approved applicant" for such CGT, and is therefore eligible for 180 days of CGT exclusivity. The exclusivity will begin from the date of the first commercial launch of Merzee. Slayback will kick off a full commercial launch under its own label very soon.
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"Approval of our ANDA in less than eight months from filing is a big milestone in our pursuit of excellence in R&D execution. Slayback continues to expand its portfolio and is committed to bringing high quality and affordable generics to the US market," Ajay Singh, CEO of Slayback Pharma, said.
MERZEE is an estrogen/progestin combination oral contraceptive (COC) indicated for use by women to prevent pregnancy. One capsule is taken daily in order as provided in the blister pack. The efficacy of MERZEE in women who are obese (mass index (BMI) of > 35 kg/m2) has not been evaluated.