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FDA Approves Generic Oseltamivir Phosphate Capsules

According to a press release issued by the manufacturer, the products are the therapeutic equivalent to Genentech’s Tamiflu capsules.

The US Food and Drug Administration has approved Alembic Pharmaceuticals’ Abbreviated New Drug Application for oseltamivir phosphate capsules USP, 30 mg, 45 mg, and 75 mg.

According to a press release issued by Alembic, the products are the therapeutic equivalent to Genentech’s Tamiflu capsules.

The capsules are indicated for treating uncomplicated, acute illness due to influenza A and B infection. The capsules are approved for use in patients 2 weeks of age and older, who have been experiencing symptoms of influenza for less than 48 hours. The indication also includes prophylaxis of influenza A and B in patients 1 year and older.

According to the press release, oseltamivir phosphate capsules had an estimated market size of $647 million for 12 months ending in December of 2018 according to IQIVA.