Novadoz awarded FDA approval for generic versions of Oseltamivir and Dofetilide
5 June 2020 -

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.