Benzinga | Nov 18, 2021 07:41AM EST

Endo Int'l. Reports Begun Shipping Generic MIACALCIN Injection

Endo International plc (NASDAQ:ENDP) announced today that its Par Sterile Products business has begun shipping calcitonin salmon injection, USP, multi-dose vials (2 mL) following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Par's calcitonin salmon injection is AP-rated to Viatris' MIACALCIN(r) and is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required. Calcitonin salmon injection is also used to treat postmenopausal osteoporosis in women greater than 5 years postmenopause and to treat symptomatic Paget's disease of bone when alternative treatments are not suitable for these conditions.



"We are very pleased to offer this generic, therapeutically equivalent calcitonin salmon injectable," said Scott Sims, Senior Vice President and General Manager, Sterile Injectables at Endo. "Our product is manufactured in our U.S. facility in Rochester, MI and it provides health care practitioners and their appropriate patients a cost-effective, high-quality treatment option."

According to IQVIA data, U.S. sales of calcitonin salmon injection were approximately $170M for the 12 months ended September 2021.

MIACALCIN(r) is a registered trademark of Novartis AG, licensed to the Viatris Companies.