FDA approves generic to commonly used inhaler as demand surges due to coronavirus

https://www.reuters.com/article/us-fda-cipla/fda-approves-generic-to-commonly-used-inhaler-as-demand-surges-due-to-coronavirus-idUSKCN21Q323

The U.S Food and Drug Administration on Wednesday approved reut.rs/2RnpE3h first generic of a commonly used albuterol sulfate-based inhaler, catering to increased demand from COVID-19 patients suffering from breathing difficulties.

Indian drugmaker Cipla Ltd won the approval to make the generic version of the inhaler, normally used to treat or prevent bronchospasm, a condition that causes difficulty in breathing in patients aged four or above, the FDA said.

The approval comes after the FDA reported a shortage of albuterol inhalers, which have been found to also help those suffering from COVID-19, caused by the new coronavirus. The disease has a wide range of symptoms, including fever, coughing and breathing difficulties.

“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen Hahn. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”

Earlier in March, the FDA issued a revised draft for proposed generic albuterol sulfate metered dose inhalers, including drug products referencing Merck & Co’s Proventil HFA.

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