Active pharmaceutical ingredients supplier Novadoz Pharmaceuticals reported on Thursday the receipt of the US FDA's approval for its generic versions of Oseltamivir Phosphate Capsules and Dofetilide Capsules.
According to the company, Dofetilide in 125mcg, 250mcg and 500mcg capsules is AB rated to Pfizer's brand Tykosin. Oseltamivir Phosphate in 30mg, 40mg and 75mg capsules is AB rated to Genentech Pharmaceuticals' Tamiflu.
Dofetilide is an antiarrhythmic drug used sustain a normal heart beat in patients with certain heart rhythm disorders of the atrium. It is used to treat atrial fibrillation, or atrial flutter. Combined brand and generic sales for the product exceed USD63.4m.
Oseltamivir Phosphate is used to treat symptoms caused by the flu virus (influenza) including blocked nasal passages, fever/chills, aches and fatigue. Combined sales for brand and generics amount to over USD188m.
Par Health launches generic version of Janumet XR tablets in US
EQL Pharma gains approval to sell Mellozzan in Kazakhstan
Newbury Pharmaceuticals receives Swedish approval for generic tofacitinib
Breckenridge launches Tofacitinib Tablets, generic equivalent to Pfizer's Xeljanz
Hims & Hers expands GLP-1 offering in Canada with generic semaglutide
Apotex announces commercial launch of Apo-Semaglutide Injection in Canada
Transpire Bio's generic high-strength Trelegy Ellipta ANDA accepted for filing by US FDA
Kaiser Permanente reports study findings showing significant cost savings
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