Glenmark Pharma gets USFDA nod for generic version of Brovana inhalation solution

Glenmark Pharmaceuticals today announced that it has become one of the first generic companies to receive United States Food & Drug Administration (USFDA) approval for Arformoterol Tartrate inhalation solution, 15 mcg/2 ml, unit-dose vials, the generic version of Brovana inhalation solution of Sunovion Pharmaceuticals.   

The drug will be manufactured in the company’s North American manufacturing facility based in Monroe (North Carolina) and will mark the first nebuliser approval of the company. This also marks the company’s third approval from the state-of-the-art Monroe facility in 2021, which has demonstrated the capability to offer high-quality medicines with affordable access across multiple dosages platforms.   

According to IMS Health (IQVIA) sales data for the 12-month ending April 2021, Brovana inhalation solution drug achieved annual sales of around US$ 437.9 million.   

Glenmark’s current portfolio consists of 172 products authorised for distribution in the US marketplace while 44 ANDAs are still pending approval with USFDA. 

At 2.50 pm on Wednesday, the stock of Glenmark Pharmaceuticals was trading at Rs 637.80, down by 0.45 per cent as against a 0.42 per cent decline in the benchmark index. The 52-week high and 52-week low of the scrip was recorded at Rs 658 and Rs 405.10, respectively on BSE.