Alembic’s generic Tamiflu gets FDA approval
Alembic Pharmaceuticals has received the Food and Drug Administration’s blessing for oseltamivir phosphate capsules, in dosage strengths of 30 mg, 45 mg, and 75 mg.
The product is the generic of Hoffman-La Roche’s Tamiflu capsules.
It is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients two weeks of age and older who have been symptomatic for no more than 48 hours. In addition, it is also indicated for the prophylaxis of influenza A and B in patients one-year-old and older.
Oseltamivir phosphate capsules have a market value of $647 million for the 12 months ending December 2018, according to IQVIA.
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