Akorn receives FDA OK for generic Cetrotide

Akorn has obtained the Food and Drug Administration’s permission for Cetrorelix acetate for injection 0.25 mg.

This medication is the first approved generic of Merck Serono's Cetrotide.

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“We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments,” said Akorn president and CEO Douglas Boothe. “As an increasing number of infants are being conceived via the use of ART, Akorn is excited to be able to offer a competitively priced option to support women who undergo this series of treatments. This is a welcome addition to our portfolio of more than 200 specialty and injectable generics.”

Assisted Reproductive Technology is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy.

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The FDA granted Akorn a Competitive Generic Therapy designation for Cetrorelix. 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.

Cetrorelix had a market value of roughly $63 million through June 2022, according to IQVIA.