Strides Arcolab gets USFDA approval for Tacrolimus capsules

MUMBAI: Pharma firm, Strides Arcolab today announced that it has received approval from the United States Food & Drug Administration ( USFDA) for marketing of Tacrolimus capsules, used as immuno-suppressant.

"We have received approval from the USFDA for Tacrolimus capsules USP, 0.5 mg, 1 mg, and 5 mg and (they) will be launched immediately," company statement said here.

The product will be manufactured at the company's oral dosage facility at Bangalore and marketed directly by Strides in the US market.

According to IMS data as on September 2013, the US market for generic Tacrolimus is approximately $ 676 million.

Tacrolimus capsule is an immunosuppressant and is used for preventing organ rejection in certain patients following liver, kidney, or heart transplant. It may be used along with other medicines. It blocks the action of certain blood cells that can cause the body to reject the transplanted organ.