Glenmark Pharma gets US health regulator nod for inhalation product

Drug maker Glenmark Pharma on Wednesday said it had received approval from the US health regulator for Arformoterol Tartrate Inhalation Solution, used to treat conditions like chronic bronchitis and emphysema, in the US market.

The approved product is a generic version of Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc.

Glenmark Pharmaceuticals has received final approval by the United States Food and Drug Administration (USFDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, unit-dose vials,” the company said in a regulatory filing.

Glenmark Pharma said the Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in the company’s North American manufacturing facility based in Monroe, North Carolina, and marks the company’s first nebulizer approval.

Quoting IQVIA sales data for the 12 months period ending April 2021, the Brovana Inhalation Solution, 15 mcg/2 mL market achieved annual sales of approximately USD 437.9 million.

Sanjeev Krishan, President, Glenmark North America said, We are very excited to be one of the first generic companies to receive approval for such an important product for our customers.

Glenmark’s current portfolio consists of 172 products authorised for distribution in the US marketplace and 44 abbreviated new drug applications’ pending approval with the USFDA.

(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