FDA approves generic cetrorelix acetate injection

The US Food and Drug Administration has approved cetrorelix acetate for injection (Akorn Operating Company, a Calyptus partner), a generic version of Cetrotide (Merck Global), for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian stimulation.¹

Controlled ovarian stimulation is a fertility process by which oral and/or injectable medications are administered to induce superovulation in the ovulatory patient, and ovulation in the anovulatory patient.

“As an industry leader in specialty injectable offerings, Akorn is uniquely positioned to launch the product in the US. We are excited that this approval will broaden accessibility to medication for patients undergoing controlled ovarian stimulation,” said Calyptus co-founders Sujeet Singh, Dr. Puiho Yuen, and Shubhayu Sinharoy.

They added, “This is an important milestone for Calyptus and further validates our impressive track record of selecting and developing complex sterile dosage forms with an eye toward execution, along with our ability to piece together complex supply chains."

Reference:

Calyptus pharmaceuticals announces FDA approval of cetrorelix acetate for injection, 0. 25 mg/vial. PR Newswire. August 19, 2022. Accessed August 19, 2022. https://www.prnewswire.com/news-releases/calyptus-pharmaceuticals-announces-fda-approval-of-cetrorelix-acetate-for-injection-0-25-mgvial-301608717.htmlThe US Food and Drug Administration has approved cetrorelix acetate for injection (Akorn Operating Company, a Calyptus partner), a generic version of Cetrotide (Merck Global), for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian stimulation.1

Controlled ovarian stimulation is a fertility process by which oral and/or injectable medications are administered to induce superovulation in the ovulatory patient, and ovulation in the anovulatory patient.

“As an industry leader in specialty injectable offerings, Akorn is uniquely positioned to launch the product in the US. We are excited that this approval will broaden accessibility to medication for patients undergoing controlled ovarian stimulation,” said Calyptus co-founders Sujeet Singh, Dr. Puiho Yuen, and Shubhayu Sinharoy.

They added, “This is an important milestone for Calyptus and further validates our impressive track record of selecting and developing complex sterile dosage forms with an eye toward execution, along with our ability to piece together complex supply chains."

Reference:

Calyptus pharmaceuticals announces FDA approval of cetrorelix acetate for injection, 0. 25 mg/vial. PR Newswire. August 19, 2022. Accessed August 19, 2022. https://www.prnewswire.com/news-releases/calyptus-pharmaceuticals-announces-fda-approval-of-cetrorelix-acetate-for-injection-0-25-mgvial-301608717.html