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J&J seeks FDA approval for intravenous Simponi

Agency approved subcutaneous formulation in 2009

HORSHAM, Pa. — A subsidiary of Johnson & Johnson is hoping to gain Food and Drug Administration approval for a new formulation of one of its drugs.

Janssen Biotech announced that it had filed an application with the FDA seeking approval for an intravenous formulation of Simponi (golimumab) in adults with moderately to severely active rheumatoid arthritis, which affects an estimated 1.5 million Americans.

The FDA approved the subcutaneously injected formulation of Simponi in April 2009 for moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.


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