Mylan NV said Thursday it was restarting production of a medication to treat malaria — hydroxychloroquine sulfate tablets — that could potentially treat COVID-19 if it's approved by the federal government.
The World Health Organization has listed it as a drug under investigation for treatment against the novel coronavirus, although it isn't approved for that use in the United States. It is also used to treat rheumatoid arthritis and lupus erythematosus. Mylan said that it restarted production at its Morgantown, West Virginia, plant of the medication and has enough active pharmaceutical ingredient to start supply in mid-April and provide at some point after the ramp-up to 50 million tablets that could treat 1.5 million COVID-19 patients.
"The company is also taking steps to initiate production of this product outside the U.S. in the coming weeks," Mylan said in a statement. "We look forward to working with governments and health authorities globally to ensure patient access to this medicine as and where needed."
President Trump during a White House news conference on Thursday said the country would be able to start making hydroxychloroquine sulfate almost immediately and said the FDA had fast-tracked the approval process. But the FDA told Bloomberg News later Thursday that the drug hadn't been approve yet to treat COVID-19.
"It's been around for a long time and it's very powerful," Trump said of the medication. "But the nice part is that it's been around a long time, so that we know if things don't go as planned, it's not going to kill anybody."
Mylan said in its statement hours after the news conference that it needed to get additional FDA approval and other regulatory guidance before it could be used to treat COVID-19.
Source Pittsburg Business news
The World Health Organization has listed it as a drug under investigation for treatment against the novel coronavirus, although it isn't approved for that use in the United States. It is also used to treat rheumatoid arthritis and lupus erythematosus. Mylan said that it restarted production at its Morgantown, West Virginia, plant of the medication and has enough active pharmaceutical ingredient to start supply in mid-April and provide at some point after the ramp-up to 50 million tablets that could treat 1.5 million COVID-19 patients.
"The company is also taking steps to initiate production of this product outside the U.S. in the coming weeks," Mylan said in a statement. "We look forward to working with governments and health authorities globally to ensure patient access to this medicine as and where needed."
President Trump during a White House news conference on Thursday said the country would be able to start making hydroxychloroquine sulfate almost immediately and said the FDA had fast-tracked the approval process. But the FDA told Bloomberg News later Thursday that the drug hadn't been approve yet to treat COVID-19.
"It's been around for a long time and it's very powerful," Trump said of the medication. "But the nice part is that it's been around a long time, so that we know if things don't go as planned, it's not going to kill anybody."
Mylan said in its statement hours after the news conference that it needed to get additional FDA approval and other regulatory guidance before it could be used to treat COVID-19.
Source Pittsburg Business news