First Time Generic Approval for Flu Drug
The Food and Drug Administration (FDA) has approved the abbreviated New Drug Application (ANDA) for the first generic version of Tamiflu(oseltamivir phosphate Roche) for the treatment of influenza A and B in patients aged ≥2 weeks who have had flu symptoms for no more than 48 hours, and for the prevention of flu in patients aged ≥1 year.
The FDA's Office of Bioequivalence has determined Alvogen's Oseltamivir Phosphate Capsules, USP, to be bioequivalent and therefore, therapeutically equivalent to the reference listed drug, Tamiflu.
Oseltamivir phosphate is an ethyl ester prodrug requiring ester hydrolysis for conversion to the active form, oseltamivir carboxylate. Oseltamivir carboxylate is an inhibitor of influenza virus neuraminidase affecting release of viral particles. Its antiviral activity against laboratory strains and clinical isolates of influenza virus was determined in cell culture.
Oseltamivir Phosphate will be available as 30mg, 45mg, and 75mg strength capsules.
For more information call (866) 770-3024 or viist Alvogen.com.