Swedish pharmaceutical company Newbury Pharmaceuticals AB (STO:NEWBRY) announced on Monday that it has received marketing authorisation in Sweden for Tofacitinib Newbury 5 mg and 10 mg film-coated tablets, marking the first approval in a Scandinavian registration procedure.
Approvals in Norway and Denmark are expected following the completion of national reviews.
Tofacitinib Newbury, an oral Janus kinase (JAK) inhibitor, is a generic version of Xeljanz and is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis. Newbury said the approval marks its entry into the immunology market, complementing its oncology, rare diseases and neurology portfolio, while targeting a Scandinavian market estimated at EUR19.3m annually.
Apotex receives Health Canada approval for a generic Ozempic equivalent
Cipla's AB-rated Ventolin HFA generic receives US FDA approval
Newbury Pharmaceuticals secures first Scandinavian approval for palbociclib generic
Apotex's generic Ozempic (Semaglutide Injection) receives US FDA tentative approval
DifGen and Apotex report FDA approval of generic Nintedanib Soft Gel Capsules
Dexcel Pharma's Nintedanib Capsules approved for US launch
Upsher-Smith launches generic version of Ciprodex ear drop suspension
Samsung Bioepis partners with Sandoz on up to five next-generation biosimilars
Breckenridge Pharmaceutical partners with sterile injectable manufacturer Maiva Pharma
Breckenridge Pharmaceutical launches Pomalidomide Capsules in US market
Cipla launches generic liraglutide injection in the US
Arna Pharma signs MOU with Slate Run Pharmaceuticals
STADA and Bio-Thera Solutions receive European marketing authorisation for Gotenfia (golimumab)
DifGen Pharmaceuticals' Fluorometholone Ophthalmic Suspension, 0.1% receives FDA approval