Lupin Ltd in alliance with Concord Biotech has received approval from the United States Food and Drug Administration for Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg. The drug is indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients of at least 5 years of age and older who are at least 6 months into the post-kidney transplant phase. The drug has an annual sales of approximately $174 million in the US.
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