With this approval, the company said it would market a generic equivalent of Myfortic delayed release tablets of Novartis Pharmaceuticals Corporation,
Shares of Lupin gained more than a percent intraday on December 19 after the pharma major received approval from the US health regulator for a drug that prevents organ rejection after a kidney transplant.
Lupin's alliance partner Concord Biotech has received approval for Mycophenolic acid delayed-release tablets USP, 180 mg and 360 mg, from the United States Food and Drug Administration.
With this approval, the company said it would market a generic equivalent of Myfortic delayed-release tablets of Novartis Pharmaceuticals Corporation,
Mycophenolic 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.
The drug will be used in combination with cyclosporine and corticosteroids, the company said in its BSE filing.
Mycophenolic tablets had an annual sales of approximately $174 million in the US, as per IQVIA MAT data of September 2019.
In addition, the pharma major announced the launch of Doxercalciferol injection, 4 mcg/2 ml (2 mcg/mL) multi-dose vials in the US.
The drug, which is the therapeutic generic equivalent of Sanofi Genzyme's Hectorol injection, is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis, the company said.Doxercalciferol had an annual sales of approximately $132 million in the US, as per IQVIA MAT data of October 2019.Get access to India's fastest growing financial subscriptions service Moneycontrol Pro for as little as Rs 599 for first year. Use the code "GETPRO". Moneycontrol Pro offers you all the information you need for wealth creation including actionable investment ideas, independent research and insights & analysis For more information, check out the Moneycontrol website or mobile app.