Leucadia is debuting calcitonin salmon injection, synthetic.
The product is the generic of Mylan's Miacalcin and is indicated for the early treatment of hypercalcemic emergencies when a rapid decrease in serum calcium is required.
Calcitonin salmon injection also is used to treat osteoporosis in postmenopausal women and Paget’s disease.
“This is Leucadia’s fourth FDA approval for a first generic injectable in less than two years,” said William Larkins, CEO of Leucadia Pharmaceuticals. “Calcitonin salmon injection, once again demonstrates Leucadia’s commitment to the development and launch of critically needed, lower cost therapies in the generic injectables market.”
Leucadia is the first approved applicant for CGT designation and is eligible for 180 days of market exclusivity which begins with the commercial marketing of the product.