Subject: FDA
Calyptus Pharmaceuticals Announces Approval of Arformoterol Tartrate Inhalation Solution, EQ 0.015 mg Base/2 ml
PRINCETON, N.J., Aug. 24, 2022 /PRNewswire/ -- Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for a generic version of Brovana® (Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml) to Calyptus' partner - VistaPharm, Inc., ("VistaPharm" - a Pharmaceutical Associates, Inc company). Calyptus co-developed the product in collaboration with VistaPharm. Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Arformoterol Tartrate inhalation solution is for use by nebulization only.
Calyptus Co-founders - Sujeet Singh, Dr. Puiho Yuen and Shubhayu Sinharoy said, "We are thrilled with this approval in partnership with VistaPharm. We believe that combining Calyptus' know-how and expertise with partners is key to bringing affordable medicines to patients and creating shared success. The successful development, and approval of a generic formulation of Arformoterol Tartrate inhalation solution is a testimony to these efforts".
According to IQVIAtm, a leading healthcare data and analytics provider, U.S. annual sales for Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml for the 12 months ended June 2022 were approximately $104 million.
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
CONTACT
Name: Shubhayu Sinharoy, COO Calyptus Pharmaceuticals, Inc.
Email: [email protected]
Phone: 269-873-0430
Website: www.calyptuspharma.com
SOURCE Calyptus Pharmaceuticals, Inc.
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