Akorn Operating Company's generic Cetrorelix Acetate receives FDA approval
17 August 2022 -

Akorn Operating Company LLC, a US-based specialty pharmaceutical company, announced on Tuesday that it has received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25mg.

The product received a Competitive Generic Therapy (CGT) designation, which is aimed at incentivising effective development, efficient review and timely market entry of drugs for which there is inadequate generic competition. It is eligible for 180 days of CGT market exclusivity that will start to run from the commercial launch of the product.

Cetrorelix Acetate is intended to prevent premature ovulation during controlled ovarian stimulation. It blocks the effects of a natural hormone, called gonadotropin-releasing hormone (GnRH).



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