Slayback Pharma obtains FDA nod for generic Taytulla

The Food and Drug Administration has given its stamp of approval for Slayback Pharma’s Merzee (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) in a dosage strength of 1 mg/20 mcg. Merzee is an estrogen/progestin combination oral contraceptive indicated for use by women to prevent pregnancy.

Merzee is the generic of AbbVie’s Taytulla.

Slayback is the first approved applicant for Competitive Generic Therapy Designation, and is eligible for 180 days of CGT exclusivity. The exclusivity will begin from the date of the first commercial launch. 

The company said it will kick off a full commercial launch under its own label very soon.

"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 U.S. market," said Ajay Singh, CEO of Slayback Pharma.