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Biopharmaceuticals Generics FDA

 News Release - August 19, 2022

Calyptus Pharmaceuticals Announces FDA Approval of Cetrorelix Acetate for Injection, 0.25 mg/vial

PRINCETON, N.J., Aug. 19, 2022 -- (Healthcare Sales & Marketing Network) -- Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for an AP-rated generic version of Cetrotide® (Cetrorelix Acetate for Injection, 0.25 mg/vial) to Calyptus' partner - Akorn Operating Company LLC ("Akorn"). In addition, the FDA granted the Competitive Generic Therapy (CGT) designation, which makes the product eligible for 180 days of CGT market exclusivity for the 0.25 mg/vial dose. Cetrorelix Acetate for Injection, 0.25 mg/vial is indicated for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian stimulation.

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

According to IQVIA™, U.S. sales of Cetrorelix through June 2022 were approximately $63 million with full year U.S. sales projection of approximately $127 million.

About Calyptus

Calyptus is a pharmaceutical company based in Princeton, N.J., whose mission is to improve lives of patients by increasing access and affordability of quality medicines. Founded in 2017, Calyptus is developing a portfolio of sterile products (generic ANDAs and specialty 505(b)2s) that resolve technological complexity, create accelerated regulatory pathways, bridge unmet medical needs and overcome market access barriers. Additional information is available on Calyptus' website at www.calyptuspharma.com.

Source: Calyptus Pharmaceuticals

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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