Generic Influenza Therapy Receives FDA Approval

The approved product is therapeutically equivalent to Genentech’s Tamiflu I Capsules, 30 mg, 45 mg, and 75 mg.

Officials with the FDA have approved Alembic Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for Oseltamivir Phosphate Capsules USP, 30 mg, 45 mg, and 75 mg.1

The approved product is therapeutically equivalent to Genentech’s Tamiflu I Capsules, 30 mg, 45 mg, and 75 mg.1 Genentech is a member of the Roche Group.2

Oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients ages 2 weeks and older who have been symptomatic for no more than 48 hours. It is also indicated for the prophylaxis of influenza A and B in patients 1 year and older.1

A study of children ages 1 to12 years, oseltamivir phosphate helped improve children’s conditions up to 1.5 days (26%) faster compared with children who didn’t take this therapy within 48 hours of first symptoms.2

This therapy can also reduce the risk of acquiring the flu in individuals ages 1 year and older, according to Genentech.2

Oseltamivir phosphate capsules has an estimated market size of $647 million for 12 months ending December 2018, according to IQVIA.1

References

  • Alembic Pharmaceuticals receives USFDA Approval for Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base) [news releasel]. Vadodara, India; June 25, 2019: Alembic website. https://www.alembicpharmaceuticals.com/wp-content/uploads/2019/06/Press-Release-Oseltamivir-Phosphate-Capsules-June-2019.pdf. Accessed June 25, 2019.
  • Genentech. Antiviral Tamiflu in liquid form is FDA-Approved to treat flu in people 2 weeks of age and older. Tamiflu website. https://www.tamiflu.com/patient/tamiflu-for-children.html. Accessed June 25, 2019.