Teva gains FDA approval for generic form of Forteo for certain patients with osteoporosis
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Teva Pharmaceuticals announced FDA approval of a generic version of Forteo in the U.S. for certain women and men with osteoporosis, according to a company press release.
The generic equivalent of teriparatide injection uses the Antares Pharma multidose pen device.
The approval applies to postmenopausal women with osteoporosis at high risk for fractures or who cannot use other osteoporosis treatments, as well as to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fractures and cannot use other osteoporosis treatments, and for both men and women with osteoporosis due to use of glucocorticoid medicines for several months who are at high risk for fractures and cannot use other osteoporosis treatments, according to the release.
Of note, the safety and efficacy of teriparatide injection in children is unknown. Therefore, teriparatide injection should not be used in children and young adults.
“We are thrilled to receive the long-awaited generic approval of this important drug-device combination product,” Eric Hughes, MD, PhD, executive vice president of global research and development and chief medical officer at Teva Pharmaceuticals, said in the release. The approval will enhance access to a critical treatment option for patients while serving to demonstrate our strategic goal of sustaining a generic powerhouse.”
According to IQVIA data, teriparatide (Forteo, Eli Lilly) had annual sales of $609 million as of July.
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