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Wednesday, Dec 07, 2022

Lupin gets USFDA nod for asthmatic symptoms prevention drug

In a regulatory filing, Lupin said it has received approval from the United States Food and Drug Administration (USFDA) for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation.

The Lupin Ltd. pharmaceutical plant stands in Salcette, Goa, India, on Friday, Feb. 7, 2014. (Photographer: Dhiraj Singh/Bloomberg)

Drug major Lupin on Tuesday said it has received approval from the US health regulator for its Albuterol Sulfate Inhalation Aerosol, used for treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

The approved product is a generic version of ProAir HFA of Teva Branded Pharmaceutical Products R&D, Inc.

In a regulatory filing, Lupin said it has received approval from the United States Food and Drug Administration (USFDA) for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation.

Vinita Gupta, CEO, Lupin said: “The approval is timely as Albuterol MDI is a key rescue inhalation product for asthma patients who are at an increased risk of COVID-19-related complications. We look forward to launching the product this quarter and expect a steady ramp-up through the fiscal year.”

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Quoting IQVIA moving annual total June 2020 data, Lupin said the total Albuterol Sulfate Inhalation Aerosol market had US sales of approximately USD 2.9 billion, of which the ProAir HFA market accounted for USD 1.3 billion.

Shares of Lupin were trading 0.99 per cent higher at Rs 979.75 apiece on BSE.

First published on: 25-08-2020 at 12:57:48 pm
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