Lupin gets USFDA nod to market generic injection for kidney disease

Drug firm Lupin Monday said it has received approval from the US health regulator to market its generic Doxercalciferol injection in the American market.

The company has received approval from the United States Food and Drug Administration (USFDA) to market its Doxercalciferol injection, 4 mcg/2 mL (2 mcg/mL) multi-dose vials, Lupin said in a statement.

The product is a generic version of Sanofi Genzyme's Hectorol injection, it added.

As per the IQVIA MAT September 2018 data, Doxercalciferol injection, 4 mcg/2 mL (2 mcg/mL) multi-dose vials had annual sales of around USD 133 million in the US, Lupin said.

The product is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, it added.

Shares of Lupin were trading at Rs 853.60 per scrip on BSE, up 0.49 per cent from their previous close.

Dear Reader,

Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel