Glenmark Pharma gets USFDA nod for inhalation product

Glenmark Pharma gets USFDA nod for inhalation product

PTIUpdated: Wednesday, June 23, 2021, 11:16 AM IST
article-image
Glenmark | Photo credit: Twitter

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 $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.

RECENT STORIES

X Slashes Premium Account Subscription Fee For Mobile App By 48%

X Slashes Premium Account Subscription Fee For Mobile App By 48%

DMart's Operator Avenue Supermarts Sees Consolidated Net Profit Fall Marginally In First Quarter Of...

DMart's Operator Avenue Supermarts Sees Consolidated Net Profit Fall Marginally In First Quarter Of...

Market Outlook: Weekly Market Review & Top Stocks that were in Focus for the week ended 11th...

Market Outlook: Weekly Market Review & Top Stocks that were in Focus for the week ended 11th...

India's Gold Reserves Rise By $342 Million, Forex Stands At $699.736 Billion: RBI

India's Gold Reserves Rise By $342 Million, Forex Stands At $699.736 Billion: RBI

Mumbai: Back Pain A 'Silent Epidemic' In India, Says Gautam Adani At Spine Surgery Conference...

Mumbai: Back Pain A 'Silent Epidemic' In India, Says Gautam Adani At Spine Surgery Conference...