Teva obtains FDA nod for generic Forteo

Teva Pharmaceuticals has received the Food and Drug Administration’s approval for generic Forteo.

The product is expected to be available in the coming weeks.

“We are thrilled to receive the long-awaited generic approval of this important drug-device combination product,” said Eric Hughes, executive vice president of global R&D and chief medical officer. “This approval showcases Teva’s exceptional strengths in complex generic formulations development and device engineering, which support our ambitions to focus our generics pipeline on medicines that deliver the highest impact to patients. The approval will enhance access to a critical treatment option for patients while serving to demonstrate our strategic goal of sustaining a generic powerhouse.”

[Read more: Teva rolls out generic Nexavar tablets]

Teva’s generic Forteo utilizes the Antares Pharma's multi-dose pen device. Antares, a wholly owned subsidiary of Halozyme Therapeutics and Teva are parties to an exclusive license, development and supply agreement for Teriparatide auto injector product that Teva markets in the EU and will market in the United States.

Teriparatide injection is a prescription medicine used to : treat postmenopausal women who have osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. Teriparatide injection can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis; increase the bone mass in men with primary or hypogonadal osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments; and treat both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments.

Forteo had a market value of $609 million as of July 2023, according to IQVIA data.

[Read more: Teva rolls out generic Votrient]