Lupin gets USFDA approval for Albuterol Sulfate Inhalation Aerosol
Lupin Limited has informed the bourses that it has received United States Food and Drug Administration (USFDA) approval for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation. It is a generic version of ProAir HFA.
Lupin’s generic Albuterol Sulphate MDI will be manufactured at its Indore (Unit III) facility in India.
As per the data provided by IQVIA MAT for June 2020, the total Albuterol Sulfate Inhalation Aerosol market had US sales of approximately USD 2.9 billion, of which, ProAir HFA market accounted for USD 1.3 billion.
ProAir HFA (Albuterol Sulfate Inhalation Aerosol) is the registered trademark of Teva Branded Pharmaceutical Products R&D, Inc. and is indicated for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.
Bronchospasm occurs when the airways i.e. bronchial tubes go into spasm and contract, which makes it hard to breathe and causes wheezing as well as frequent coughing without wheezing (a high-pitched whistling sound). Asthma is an inflammatory disease of the airways to the lungs that makes breathing difficult as well as some physical activities challenging or even impossible.
Lupin stated that this approval has come in time as Albuterol MDI is a key rescue inhalation product for asthma patients, who are at an increased risk of COVID-related complications. The company would be launching the product this quarter and expects a steady ramp up through the fiscal year.
On Tuesday, the stock of Lupin opened gap-up 5.2 per cent at Rs 1,021 from its previous close of Rs 970.10 on BSE.