Lupin gets US health regulator nod to market hypothyroidism tablets

Topics Lupin Pharma | USFDA

Drug firm Lupin on Friday said it has received approval from the US health regulator to market its generic Levothyroxine Sodium tablets in the American market.

The tablets are indicated for the treatment of hypothyroidism and pituitary thyrotropin suppression, Lupin said in a statement.

The company has received approval from the United States Food and Drug Administrtion (USFDA) for its supplemental abbreviated new drug application (sANDA) to market its Levothyroxine Sodium tablets in the strengths of 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg, it added.

The product is a generic version of King Pharmaceuticals Research and Development LLC's Levoxyl tablets in same strengths, Lupin said.

With this approval, the company's product is now generic version of ABBVIE Inc's Synthroid tablets, Jerome Stevens Pharmaceuticals Inc's Unithroid tablets and Levoxyl tablets of King Pharmaceuticals Research and Development LLC, it added.

It is the only product approved with FDA's new narrow therapeutic index guidance for Levothyroxine, Lupin said.

The cumulatively Levothyroxine Sodium tablets USP had annual sales of around USD 2,581 million in the US, Lupin said.

Shares of Lupin Ltd closed at Rs 765.70 per scrip on the BSE, up 2.69 per cent from its 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