Teva Pharmaceuticals Inc, a US affiliate of Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd (NYSE:TEVA) (TASE:TEVA), announced on Friday the regulatory approval of its generic version of Forteo (teriparatide injection) in the United States.
This approval is set to enhance patient access to a crucial osteoporosis treatment. Market availability of the generic Forteo in the US is anticipated in the coming weeks.
Teriparatide injection is prescribed to address osteoporosis in specific demographics, including postmenopausal women at high fracture risk and men with primary or hypogonadal osteoporosis. It also caters to individuals with glucocorticoid-induced osteoporosis.
Forteo generated annual sales of USD609m as of July 2023, according to IQVIA data.
Teva has nearly 500 FDA-approved generic products, and 1 in 12 generic prescriptions dispensed in the United States is filled with a Teva generic product.
Its generic equivalent of Forteo employs the Antares Pharma Inc multi-dose pen device, part of an exclusive licence, development and supply agreement with Antares, a wholly owned subsidiary of Halozyme Therapeutics Inc (Nasdaq:HALO). This agreement encompasses the marketing of Teriparatide auto injector products in the EU and the forthcoming US market.
CivicaScript to distribute biosimilar for chronic inflammatory conditions
Mallinckrodt and Endo complete merger
Zenara Pharma's Sertraline Hydrochloride Capsules generic receives US FDA approval
EQT agrees to acquire majority stake in Adalvo
Mallinckrodt receives Irish High Court ruling to combine with Endo Inc
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CivicaScript introduces low-cost multiple sclerosis treatment
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Glenmark Therapeutics launches Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC)
AB Science secures Canadian patent for AB8939, completing global IP coverage for AML treatment
Avera joins Civica to help maintain drug supplies
Apotex launches generic version of Tasigna in US market
CivicaScript launches droxidopa for symptomatic neurogenic orthostatic hypotension
Padagis' Naloxone HCl Nasal Spray 4 mg obtains extended shelf-life of 36 months
ANI Pharmaceuticals announces US launch of Nitazoxanide Tablets