Lupin gets FDA approval

Lupin announced that it has received final approval for its Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base) from the United States Food and Drug Administration (FDA) to market a generic version of Hoffman-La Roche’s Tamiflu Capsules, 30 mg, 45 mg, and 75 mg.

Lupin’s Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base) are the AB rated generic equivalent of Hoffman-La Roche’s Tamiflu Capsules, 30 mg, 45 mg, and 75 mg. Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base) are indicated for the 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 prophylaxis of influenza A and B in patients 1 year and older.