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.
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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.
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