Amphastar Pharmaceuticals (AMPH) said Monday that the US Food and Drug Administration approved the abbreviated new drug application for its teriparatide injection as a treatment for osteoporosis.

Amphastar said the teriparatide injection is intended to treat postmenopausal women with osteoporosis, to increase bone mass in men with primary or hypogonadal osteoporosis, and for patients with osteoporosis associated with sustained systemic glucocorticoid therapy.

In each of these cases, the injection is indicated for use in patients at high risk for fracture who have failed or are intolerant to other available osteoporosis therapies, the company said.

Amphastar said it plans to launch the injection, sold as a single-patient-use prefilled pen, by the end of the year.

The FDA has determined that Amphastar's teriparatide is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO, according to Amphastar.