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The US Food and Drug Administration. USA It approved Indian drug maker Cipla Ltd to make the generic version of the albuterol sulfate-based inhaler in an attempt to help coronavirus patients.
- Reuters
- Last update: April 9, 2020, 11:42 a.m. IST
New Delhi: The U.S. Food and Drug Administration approved the first generic albuterol sulfate-based inhaler on Wednesday, catering to the increased demand for COVID-19 patients suffering from respiratory difficulties.
Indian drug maker Cipla Ltd has been approved to make the generic version of the inhaler, normally used to treat or prevent bronchospasm, a condition that causes difficulty breathing in patients four years of age and older, the FDA said.
The approval comes after the FDA reported a shortage of albuterol inhalers, which have also been found to help people with COVID-19 caused by the new coronavirus. The disease has a wide range of symptoms, including fever, cough, and shortness of breath.
“The FDA acknowledges the increased demand for albuterol products during the new coronavirus pandemic,” said FDA Commissioner Stephen Hahn. “We remain deeply committed to facilitating access to medical products to help address the critical needs of the American public.”
In early March, the FDA released a revised draft for generic Albuterol Sulfate MDIs, including medications that reference Proventil HFA from Merck & Co.