BRIEF—FDA approval for generic Tamiflu for Oral Suspension

Indian pharma major Lupin has received final approval for its Oseltamivir Phosphate for Oral Suspension from the US Food and Drug Administration to market the generic version of Swiss pharma giant Roche’s Tamiflu for Oral Suspension, 6mg/mL.

Lupin says it will commence promoting the product shortly.

Lupin’s Oseltamivir Phosphate for Oral Suspension, 6mg (base)/mL is AB rated generic equivalent of Tamiflu for Oral Suspension, 6mg (base)/mL.

The product is indicated for treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours and ii) prophylaxis of influenza A and B in patients 1 year and older.

Oseltamivir Phosphate for Oral Suspension, 6mg (base)/mL had annual sales of approximately $358 million in the USA (IQVIA MAT October 2017).

Privately-held USA-headquartered generics manufacturer Amneal Pharmaceuticals launched infuenza drug oseltamivir phosphate capsules, USP in three strengths:  30mg, 45mg and 75mg, in the USA in August 2017.