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US approves new generic to treat people suffering from respiratory conditions

Published on 25/08/20 at 01:15pm
Photo by Mikael Häggström, M.D.

The FDA has granted Lupin Ltd approval for their generic version of ProAir, which is used to prevent asthma symptoms and treat episodes of bronchospasm.

The generic, an albuterol sulphate inhalation aerosol, will be manufactured at the company’s plant in Madhya Pradesh, India. Vinita Gupta, Lupin’s Chief Executive Officer, 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.”

The albuterol sulphate inhalation aerosol market is a lucrative one, with US sales of products in this sector reaching $2.9 billion over the last year, and ProAir accounting for $1.3 billion of this revenue.

The ProAir brand is owned by Teva Pharmaceuticals. It was first approved by the FDA in January 2019, and was the first type of inhaler device with built-in sensors that connect to a companion app on a smartphone.

This approval from the FDA follows the regulatory body forcing Lupin to recall one of its other treatments. Last month, the company was made to recall 561,000 pouches of its birth control pill Mibelas 24 Fe in the US due to the FDA stating that the product had “failed impurities/degradation specifications: Out of specification result observed in related substance test”. This was a Class II recall and it is unclear if the company also sells the same formula in India.

Conor Kavanagh

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