Akorn Operating Company LLC announced that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg (Cetrorelix). This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®. Assisted Reproductive Technology (ART) is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy.

The FDA granted Akorn a Competitive Generic Therapy (CGT) designation for Cetrorelix, a designation intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition. As the first approved applicant with the CGT designation, Akorn's Cetrorelix is eligible for 180 days of CGT market exclusivity, which will begin to run from the commercial launch of Cetrorelix.