Drug major Lupin received US drug regulator's approval for Mycophenolic Acid delayed-release tablets USP.
Lupin's alliance partner Concord Biotech has received the United States Food and Drug Administration (USFDA)'s approval for Mycophenolic Acid delayed-release tablets USP, 180 mg and 360 mg. The drug is a generic equivalent of Myfortic tablets of Novartis Pharmaceuticals Corporation.Mycophenolic Acid tablets are indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. It is used in combination with cyclosporine and corticosteroids.
The drug had an annual sales of approximately $174 million in the US. (IQVIA MAT Sept ember 2019).
In a separate announcement during market hours today, Lupin said it launched Doxercalciferol injection, 4 mcg/2 ml (2 mcg/mL) multi-dose vials, having received an approval from the United States Food and Drug Administration (USFDA) earlier.
Doxercalciferol injection is the therapeutic generic equivalent of Sanofi Genzyme's Hectorol Injection. It is indicated for t he treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.
According to IQVIA, Doxercalciferol lnjection had an annual sale of $132 million in October 2019.
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Shares of Lupin were up 0.34% at Rs 768.70. The stock was trading above its 50-day moving average (DMA) placed at 750.96 and below its 20-day moving average (DMA) placed at 772.44. These levels will acts resistance and support zone in near term.
Lupin is engaged in producing, developing and marketing a range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) across the world.
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