Generics
Calyptus Pharmaceuticals' Cetrorelix Acetate for Injection, 0.25mg/vial receives Abbreviated New Drug Application approval
22 August 2022 -

Calyptus Pharmaceuticals, Inc., a United States-based pharmaceutical company, announced on Friday that its partner, Akorn Operating Company LLC, has received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for an AP-rated generic version of Cetrotide (Cetrorelix Acetate for Injection, 0.25mg/vial).

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 0.25mg/vial dose.

Cetrorelix Acetate for Injection, 0.25mg/vial is indicated for the inhibition of premature luteinising 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 US. 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.'

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