Lupin gets USFDA nod to market drug for treating relapsing sclerosis

Topics Lupin | USFDA


Drug firm Lupin on Tuesday said it has received approval from the US health regulator to market generic Dimethyl Fumarate delayed-release capsules used for treatment ofrelapsing forms of multiple sclerosis in adults.

The company has received approval from the United States Food and Drug Administration (USFDA) to market its Dimethyl Fumarate delayed-release capsules in the strengthsof 120 mg and 240 mg, Lupin said in a statement.

The product is a generic version of Biogen Inc's Tecfideradelayed-release capsules in the same strengths, it added.

The company expects to launch the productshortly,the statement said.

According to theIQVIA MAT June 2020 data, Dimethyl Fumarate delayed-release capsules had an annual sales of approximately USD 3,788 million in the US, Lupin said.

The capsulesare indicated, "for the treatment of patients with relapsing forms of multiple sclerosis (MS) , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults," it added.

Shares of Lupin Ltd were tradingat Rs1,043.85per scrip on the BSE, up 0.49 per cent over previous close.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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