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FDA approves Mylan Pharma Tacrolimus capsules

The US Food and Drug Administration (FDA) has granted approval to Mylan Pharmaceuticals for its abbreviated new drug application (ANDA) for Tacrolimus capsules, 0.5mg, 1mg and 5mg.

Tacrolimus capsules is an immunosuppressant. It blocks the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.

Mylan Pharma’s Tacrolimus capsules, 0.5mg, 1mg and 5mg is the generic version of Astellas’ Prograf capsules, a treatment to prevent rejection in people who have received certain organ transplants.

The company intends to introduce the drug immediately.