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news.Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application (ANDA) for Tacrolimus 5mg capsules.
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Tacrolimus capsules is generic equivalent to Astellas’ Prograf capsules. Watson intends to begin shipping the product immediately.
Prograf is available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5mg, 1mg or 5mg of anhydrous tacrolimus. Inactive ingredients include lactose, hydroxypropyl methylcellulose, croscarmellose sodium, and magnesium stearate.
The 0.5 mg capsule shell contains gelatin, titanium dioxide and ferric oxide, the 1mg capsule shell contains gelatin and titanium dioxide, and the 5mg capsule shell contains gelatin, titanium dioxide and ferric oxide.
Tacrolimus capsules are indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants.
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.