Indian pharma’s drug approved by FDA for the US market


Indian pharmaceutical major Glenmark Pharma has finally received approval from the US health regulator for its drug that is used to treat conditions like chronic bronchitis and emphysema, in the US market.

On Wednesday, June 23, the company said its drug Arformoterol Tartrate Inhalation Solution, can now be sold in the US.

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

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 authorized for distribution in the US marketplace and 44 abbreviated new drug applications’ pending approval with the USFDA.